Surgical devices · 21 CFR 872 Subpart E
Dental Hand Instruments
FDA device type “Instruments, Dental Hand”.
- Companies listing it
- 346261 makers
- Brands and models
- 1,371
- 510(k) clearances
- 160 in five years
- FDA name
- Instruments, Dental Hand
510(k) clearances per year, 1976–2026
Companies that list DZN
346 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Institut Straumann AG | Switzerland | Maker | Neodent Dental Hand Instruments | 212 | 2026 |
| Dentsply Sirona, Inc. | United States | Maker | Palodent | 148 | 2026 |
| Shofu Inc | Japan | Maker | BEAUTIFIL Needle Tips 18G · BEAUTIFIL Needle Tips 20G · BEAUTIFIL Needle Tips 20G-L · BeautiSealant Needle Tips 23G · +2 | 96 | 2025 |
| GC America Inc. | United States | Maker | Fuji Spatula · GC Occlusal Matrix · StickCARRIER · StickSTEPPER | 137 | 2026 |
| Zest Anchors, LLC | United States | Maker | — | 26 | 2026 |
| Guilin Woodpecker Medical Instrument Co., Ltd. | China | Maker | Dental Explorer · Sharpening Tool Bits | 12 | 2025 |
| Ossvis Co., Ltd. | South Korea | Maker | OV Dental Mallet | 7 | 2024 |
| Sybron Dental Specialties | United States | Maker | Adapt Luciwedge · Blue Cervical Foils · Blue Cervical Matrices · Blue Transparent Molar & Premolar Bands · +26 | 203 | 2026 |
| Ultradent Products, Inc. | United States | Maker | Enamelast Application Brushes · ExperTemp Dispensing Gun · Impression Dispensing Gun · INTERGUARD · +4 | 95 | 2026 |
| KLS Martin SE & Co. KG | Germany | Maker | — | 43 | 2026 |
| Kulzer, LLC | United States | Maker | Dispensing Gun 10:1 · Dispensing Gun 2 (1:12:1) · Dispensing Gun 4:1 | 37 | 2026 |
| Ivoclar Vivadent, AG | United States | Maker | Cavifil Injector · OptraSculpt Instruments · OptraStick | 94 | 2026 |
| Inter-Med, Inc. | United States | Maker | Vista-Pak packing instrument, circlet, plain tip · Vista-Pak packing instrument, circlet, serrated tip · Vista-Pak packing instrument, standard, plain tip · Vista-Pak packing instrument, standard, serrated tip | 7 | 2026 |
| Paltop Advanced Dental Solutions Inc. | United States | Maker | Abutment Screw Retrieval Instrument · Conversion Handle For Latch Type · Core Tool · Extractor · +21 | 7 | 2025 |
| Premier Dental Products Company | United States | Maker | Premier Dental Products Company | 28 | 2026 |
| Young Innovations Inc | United States | Maker | AEI Dental Hand Instruments · ContactPro SmartBand · Dental Matrix Band · Flap Instruments · +2 | 23 | 2025 |
| Park Dental Research Corp | United States | Maker | LEW · StarVent | 8 | 2026 |
| Keystone Dental Inc. | United States | Maker | Genesis Implant System · Prima Dental Implant System · RENOVA Dental Implant System · RESTORE Dental Implant System · +2 | 7 | 2024 |
| ADIN DENTAL IMPLANT SYSTEMS Ltd | Israel | Maker | Prosthetic Kit Metal, Prosthetic kit tray | 3 | 2026 |
| Centrix, Inc. | United States | Maker | — | 44 | 2025 |
| Hager& Meisinger GmbH | Germany | Maker | Hand Wheel · Meisinger Bone Ring Tweezer · Meisinger Bone Scraper · Meisinger Chisel · +10 | 14 | 2025 |
| Den-Mat Holdings, LLC | United States | Maker | CeriSander · CeriSaw · Clinician's Choice® Composite Ninja · Compo-ject · +9 | 8 | 2026 |
| Pac-Dent Inc. | United States | Maker | PJ-01 ProJect Composite Dispensing Gun | 5 | 2022 |
| Premium Plus (Dongguan) Limited | China | Maker | Composite syringe gun, composite syringe tips | 2 | 2025 |
| Coltene/Whaledent AG | Switzerland | Maker | Bending Tools · Metal Wrench A · Metal Wrench B · Parapost Paraform including: Coreformer Refills, Sets & Kits | 45 | 2022 |
| DIO Corporation | South Korea | Maker | Beak Action Chisel · Bone Condenser · Bone File · Crestal Elevator · +84 | 14 | 2023 |
| Ortho Organizers, Inc. | United States | Maker | Archwire Markers · BRACKET PLACEMENT/POSITIONER · Carriere SLX 3D EZ Twist Opener Tweezer · Carriere SLX CFI Opening Tool · +9 | 8 | 2025 |
| Tp Orthodontics, Inc. | United States | Maker | Bite Stick · Orthodontic instruments · Swivel Key | 5 | 2022 |
| A.B. Dental Devices , Ltd. | Israel | Maker | Analog for Angular Adaptor 17+30 · Analog for P24 Abutments · Cone carrier Long · Digital Analog for P24 MU · +51 | 4 | 2026 |
| Garrison Dental Solutions LLC | United States | Maker | LM Instruments, Reel Matrix | 3 | 2024 |
| Ze Fang Technology Co., Ltd. | Taiwan | Maker | AL HANDLE L · AL HANDLE S · AS ALGLE BLADE L · AS ANGLE BLADE S · +18 | 1 | 2022 |
| Shenzhen Rogin Medical Co., Ltd. | China | Maker | Endo Motor, matrices, Endo Extractor · Root Canal Irrigation Needle; Matrix Strips | 1 | 2025 |
| Denjoy Dental Co., Ltd. | China | Maker | ENDO HAND FILE · HAND FILE, ROTARY FILE | 1 | 2025 |
| REX Implants, Inc | United States | Maker | — | 1 | 2022 |
| Koehrer Medical Engineering GmbH | Germany | Maker | EndoCowboy · LassoTip | 1 | 2026 |
| Pulpdent Corporation | United States | Maker | Brush tips and handles · J-POD Composite Condensing Instrument | 107 | 2021 |
| Bicon, LLC | United States | Maker | Bone Expander · Chisel · Hand Reamer · Osteotome · +3 | 18 | 2015 |
| Aseptico, Inc. | United States | Maker | B00GS1Q000BAS Gutta-Smart Base Station · B00GS1Q000KIT Gutta-Smart Kit · BCPGS1Q000BET Gutta-Smart Cannula Bender · BCPGS1Q000CAP Gutta-Smart Cleaning Caps · +2 | 17 | 2015 |
| Addent, Inc. | United States | Maker | TRIMAX · VAC-TAK | 7 | 2019 |
| Forestadent Bernhard Forster GmbH | Germany | Maker | Ortho Easy Accessories | 4 | 2011 |
| Oco Biomedical | United States | Maker | DENTAL INSTRUMENTS | 4 | 2013 |
| Storz AM Mark GmbH | Germany | Maker | Applicator · Bone block forceps · Cement spatula · Cleoid discoid · +9 | 2 | 2008 |
| Suncoast Dental Corp. | United States | Maker | Bending Pliers · Boley Gauge · Bone Caliper · Bone Carrier · +16 | 2 | 1981 |
| Surgident Co., Ltd. | South Korea | Maker | DR.PARK Needle Holder · DR.PARK Tissue Forceps | 2 | 2019 |
| Cendres+Metaux SA | Switzerland | Maker | — | 2 | 2020 |
| Temrex Corp. | United States | Maker | BITE WING LOOPS · MATRIX BANDS | 2 | 2012 |
| DB Orthodontics Limited | United Kingdom | Maker | DB Orthodontics hand instruments · Ixion hand instruments | 2 | 2010 |
| Rhondium, Ltd. | New Zealand | Maker | Cementing Wedge · DME Wedge · Power Ring · QuickConnect Anatomy Band · +5 | 2 | 2016 |
| Bomei Co, Ltd. | Taiwan | Maker | — | 2 | 2021 |
| Dental Morelli | Brazil | Maker | — | 2 | 2014 |
| TAG Medical products corporation LTD | United States | Maker | Abutment Extractor Key · Angulated Multi-Unit Key · Ball Attachment Analog · CAD/CAM Multiuse ScanBody · +171 | 1 | 2015 |
| B&L Biotech Co., Ltd. | South Korea | Maker | B&L Jetip · B&L Jetip Instrument Catroviejo · B&L MTA Pallet · Jet X Change · +6 | 1 | 2006 |
| Abracadabra Implants Ltd. | Israel | Maker | DFOD - Driver For Overdenture · DPKOP - Depth Probe Key One Piece · HD - Hand Driver · HDK 125070 - Hand Driver Key 1.25 · +19 | 1 | 2021 |
| Directa AB | Sweden | Maker | Barman's Wedges · Calasept Paste Needle, CalaseptPlus Flexi-Needle, Calasept Irrigation Needle · Physics Forceps and Bumper Guards · PrepSure | 1 | 2015 |
| Zhengzhou Huaer Electro-optics Technology Co., Ltd. | China | Maker | Outie tool | 1 | 2020 |
| COLTENE Holding AG | Switzerland | Maker | ROEKO Gutta Flow® 2 Accessories (Mixing tips) | 1 | 2003 |
| World Class Technology Corporation | United States | Maker | Archwire Seating Instrument · Debonding Instrument · Director Tool · Elastic Placement Tool · +3 | 1 | 2019 |
| Bioseal | United States | Maker | — | 1 | 1988 |
| Ronvig Dental Mfg. A/S | Denmark | Maker | FLEXI-CLAMP · FLEXI-TRIX | 1 | 2006 |
| Gestenco International AB | Sweden | Maker | Plucker Aligner Remover · Rodneys Aligner Seaters | 1 | 2005 |
| KARL STORZ SE & Co. KG | Germany | Maker | Dental Hand Instruments | 1 | 1998 |
| Hespeler Orthodontics Ltd | Canada | Maker | IK OPENING INST. · OPENING INST. · SCCUTTER · SCRULER · +2 | — | — |
| Metro Medical | Pakistan | Maker | Matrix Retainers & Matrix Bands, Ivory, No. 1 · Matrix Retainers & Matrix Bands, Ivory, No. 12 · Matrix Retainers & Matrix Bands, Ivory, No. 8, 5 mm · Matrix Retainers & Matrix Bands, Nystrom, No. 1 · +4 | — | — |
| Schobell Industrial Ltda | Brazil | Maker | Base carrier - condenser · Base carrier straight · Base carrier, simple tip · Birdy screw · +15 | — | — |
| Noga Medical Products Ltd. | Israel | Maker | — | — | — |
| Signor Seven International | Pakistan | Maker | Cassette - 10 Tools SKU-CAS10P · Cassette - 5 Tools SKU-CAS05P · Cassette - 7 Tools SKU-CAS07P · Silicone Instrument Code Rings, Assorted - Large, 120/ Pk SKU 12245 · +2 | — | — |
| Shanghai Kangqiao Dental Instruments Factory | China | Maker | Gap Increasing instrument · Mathiew Needle holder TC with gold plating 125mm/140mm/160mm/180mm · Micro needle holder 14cm/16cm curved lockable · Micro needle holder 14cm/16cm straight lockable · +8 | — | — |
| Dentaurum GmbH & Co. KG | Germany | Maker | discovery pearl debonding instrument · Distal end bender · Distal end bender, double ended · Ligator · +7 | — | — |
| Carl Martin GmbH | Germany | Maker | ALGINATE SPATULA · AM GUMLIFT Q1 · AM GUMLIFT Q2 · AM GUMLIFT Q3 · +218 | — | — |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | China | Maker | dental hand instrument · Dental Instruments · Dental Tools · Resin Conveyor | — | — |
| B. Ali Impex | Pakistan | Maker | BALI · DOCTOR NICE | — | — |
| Prodont-Holliger | France | Maker | CIMENT SPATULA SP10 reference 2469SI - cement spatula sple n 9 Bliss · CIMENT SPATULA SP24 reference 246.24SI - cement spatula sple SP24 Bliss · CIMENT SPATULA SP5 reference 2465SI - cement spatula sple n 5 Bliss | — | — |
| Shenzhen Denco Medical Co Ltd | China | Maker | Endo Motor, matrices, Endo Extractor · Root Canal Irrigation Needles; Metal Matrix Strips | — | — |
| Bashir Jamil & Bros. (Pvt.), Ltd. | Pakistan | Maker | Cement Spatula No 24 · Cement Spatula No. 24A | — | — |
| TDV Dental Ltda | Brazil | Maker | ANATOMIC WEDGES · INTERDENTAL WEDGES · SeptoWedges · TRANSLUCID WEDGES | — | — |
| Practicon, Inc. | United States | Maker | Bite DX · Compo-Dot Angles · Compo-Dots · Disposable Exam Packs · +4 | — | — |
| Aspen Surgical Products | United States | Maker | Symmetry Surgical | — | — |
| Huanghua Promisee Dental Co., Ltd | China | Maker | Dental Wedge · Smart Dental Wedges | — | — |
| Falcon Surgical Co. (Pvt.) Ltd. | Pakistan | Maker | Dental Instruments | — | — |
| MC Bio s.r.l. | Italy | Maker | Diamond Tissue Punch 10mm · Diamond Tissue Punch 11.5mm · Diamond Tissue Punch 12.5mm · Diamond Tissue Punch 6mm · +2 | — | — |
| Commic Surgico | Pakistan | Maker | INSTRUMENTS, DENTAL HAND | — | — |
| Endo Tech Instruments | Pakistan | Maker | PERIODONTAL EXPLORER TUFTS #17-23 STANDARD HANDLE DOUBLE END TIPS · PERIOSTEAL ELEVATOR #EX-51 DOUBLE ENDED SMALL SIZE 2.5mm 7 1/4" | — | — |
| FKG Dentaire Sarl | Switzerland | Maker | FKG | — | — |
| Polydentia S.A. | Switzerland | Maker | API autoclavable placement instrument · clip&Splint · Cotton Roll Holder · Diamond 24 · +48 | — | — |
| Medcave Private Limited | Pakistan | Maker | Bone Graft Packer · Bone Graft Spoon | — | — |
| Nordent MFG., Inc. | United States | Maker | Nordent Gingival Cord Packer · XpressEdge Sharpener Kit | — | — |
| Panorama International | Pakistan | Maker | INSTRUMENTS, DENTAL HAND | — | — |
| Denovo Dental Inc | United States | Maker | D071514 · D071515 · D071516 · D071517 · +4 | — | — |
| Accompany Surgical | Pakistan | Maker | Cord Packing Instrument · Matrix Retainer · OPENING AND PLACER TOOL | — | — |
| Shanghai Jolly Industrial Co., Ltd. | China | Maker | Disposable Irrigation needles · Instruments, dental hand · Plastic wedge · Wooden wedge | — | — |
| Lacigrus International | Pakistan | Maker | INSTRUMENTS, DENTAL HAND | — | — |
| Pascal International | United States | Maker | RAFORMER | — | — |
| Comfort Surgical Instruments | Pakistan | Maker | mirror handle | — | — |
| GoldenDent | United States | Maker | Deep Margin Elevation Wedge · physics forceps · Quick Connect Anatomy Band · Quick Connect Intro Kit · +1 | — | — |
| Aesculap AG | Germany | Maker | Aesculap · Dental | — | — |
| Dentatus AB | Sweden | Maker | Dentatus Matrix Bands · Forms-to-Fit | — | — |
| PDT Inc. | United States | Maker | PDT, Inc. | — | — |
| Shanghai Lions Industrial Co., Ltd. | China | Maker | instruments, dental hand, disposable Irrigation needles, Plastic wedge, wooden wedge | — | — |
| Adolf Schweick Hardt GmbH & Co | Germany | Maker | INSTRUMENTS, DENTAL HAND | — | — |
| Confident Instruments | Pakistan | Maker | Artman Instruments | — | — |
| Tangshan Zhengtong Exhibition Co., Ltd. | China | Maker | Dental Dispensing Gun · Dental Hand Instrument · Dental Wedge · Diamond Wedges · +3 | — | — |
| Denta Craft Instruments | Pakistan | Maker | Cord Packing Instrument; Matrix Retainer; OPENING AND PLACER TOOL | — | — |
| ZOGEAR Medical Co., Ltd. | China | Maker | INSTRUMENTS, DENTAL HAND | — | — |
| Medisporex Private Limited | Pakistan | Maker | MEDIS | — | — |
| Otto Leibinger GmbH | Germany | Maker | Bone Scraper · Gauze Packer | — | — |
| Solventum US LLC | United States | Maker | — | — | — |
| Dentag SRL | Italy | Maker | DENTAG | — | — |
| Garish Apparels | Pakistan | Maker | Tamzon Instruments Inc. | — | — |
| Acme Enterprises | Pakistan | Maker | TBS Dental | — | — |
| Micro Precision Swiss, LLC | United States | Maker | 05¿ Hex Driver, FP-20121 | — | — |
| W.H. Holden Inc. DBA H & H Company | United States | Maker | DENTAL HAND | — | — |
| Acheron Instruments (Pvt.) Ltd. | Pakistan | Maker | Cement Spatulas | — | — |
| Anqing Clean Dental Instrument Technology Co Ltd | China | Maker | Air Water Syringe Tips · dentrure box/ retainer case/denture retainer boxes · INSTRUMENTS, DENTAL HAND · SS dental surgical tray/box/wedge | — | — |
| Hubei Guarddent Medical Technology Co.,Ltd | China | Maker | Dental Wedges/Smart Dental Wedges · Gingival drainage | — | — |
| Goldman Products, Inc. | United States | Maker | Goldman · Micro-Dent | — | — |
| BH Medical Products Co., Ltd | China | Maker | Wedge | — | — |
| Huizhou Videya Technology Co., Ltd. | China | Maker | VDEYA, Dental matrix band, Model 1.398mm, 1.330mm, 050mm, 035mm · VDEYA, Endo Irrigation Needle, Model 18G, 20G, 22G, 23G, 25G, 27G, 30G | — | — |
| Surgiscape | Pakistan | Maker | INSTRUMENTS, DENTAL HAND | — | — |
| Cangzhou Lankang Medical Instruments Developing Co., Ltd. | China | Maker | Glass Dappen Dish, Dental Mixing Stick · Mixing Bowl, Mixing Cup, Plastic Dappen Dish, Grinding Bowl, Medicine Bottle | — | — |
| Guangzhou Xinuo Technology Co., Ltd | China | Maker | Spatular | — | — |
| Jiangsu Yabaobao Medical Instrument Co.,Ltd. | China | Maker | — | — | — |
| Maryam Trading | Pakistan | Maker | INSTRUMENTS, DENTAL HANDLE | — | — |
| Shenzhen Senlede Technologies Co., Ltd | China | Maker | Spatular | — | — |
| Bioclear Matrix Systems, LLC | United States | Maker | Adjustable Push-Pull · Clark Explorer · Curved Micro Pliers · Curved Sculpting Paddle · +10 | — | — |
| Choose Surgical Instruments | Pakistan | Maker | INSTRUMENTS, DENTAL HAND | — | — |
| Mident Ltd | United Kingdom | Maker | Matrix Bands · Retraction Cord Packer | — | — |
| ArtCraft Dental, Inc. | United States | Maker | Max Crown Spreader | — | — |
| READY SET IMPORT dba Mynt Professional | United States | Maker | — | — | — |
| TF New Material Sci and Tec Co.,ltd | China | Maker | Dental Wedges | — | — |
| Medline Industries, LP | United States | Maker | Medline / Konig Instruments, Dental Hand | — | — |
| Qibei Technology Co., Limited | China | Maker | Dental handheld instruments · MT01,MT02,MT03,MT05,MT06 | — | — |
| Y. Z. Corporation | Pakistan | Maker | YZ Hand Instruments | — | — |
| Crown Surgical Corp. | Pakistan | Maker | CROSURG | — | — |
| HuangHua DK Dental Co., LTD, | China | Maker | Mouth Props,ENDO MEASURE BLOCK,ENDO CLEAN BLOCK;ENDO Ring and Chshions · Poly Wedge;wooden wedge; Silicone Rubber Mixing Tips | — | — |
| LM-Instruments Oy | Finland | Maker | LMArte · LMDental · LMErgoAccess · LMErgoMax · +6 | — | — |
| B. Braun Medical Industries Sdn. Bhd | Malaysia | Maker | Aesculap | — | — |
| Henan Baistra Medical Devices Limited | China | Maker | INSTRUMENTS, DENTAL HAND | — | — |
| Henan Lusterdent Medical Instrument Co.,Ltd | China | Maker | Endo Motor / Rotary Motor / Endodontic Apex Locator. | — | — |
| Medesy Srl | Italy | Maker | medesy | — | — |
| Ortho Solutions LC | United States | Maker | — | — | — |
| Hangzhou Wise Medical Device Co.,Ltd | China | Maker | Micro screw drive handles, Orthodontic Tools, Self-ligation Tools | — | — |
| Mian Shahid Corp. | Pakistan | Maker | INSTRUMENTS, DENTAL HAND | — | — |
| Zirc Dental Products Inc | United States | Maker | Cement Spatula · Derlin Spatula · Mighty Mixer Bowl · Mighty Mixer Spatula · +2 | — | — |
| CDM Center of Excellence Ltd. | China | Maker | Instruments, Dental Hand | — | — |
| Gavin Biotechnology Co.,ltd | China | Maker | Dental Apex Locator | — | — |
| Laboratorios Dentales de Zona Franca, S.A. | Costa Rica | Maker | Duplication stent | — | — |
| Specialty Appliances, LLC | United States | Maker | M.A.R.A. Torqueing Tool | — | — |
| Volgo Care International (Private) Limited | Pakistan | Maker | VOLGOCARE | — | — |
| Zhejiang Yamei Medical Equipment Technology Co., Ltd. | China | Maker | Dental Wedge · Mouth Props, Endo Measure Block,Endo Clean Stand | — | — |
| Xiantao S&J Protective Products Co., Ltd | China | Maker | Disposable Dental Kits, Oral Care Kits, Personal Hygiene Kits | — | — |
| Dentech Corp. | Japan | Maker | INSTRUMENTS, DENTAL HAND | — | — |
| Hefei Mlush Sanitary Products Co., Ltd | China | Maker | Dental Wedges | — | — |
| SGS Export Intl. | Pakistan | Maker | — | — | — |
| Shenzhen Golden Wish Personal Care Co.,Ltd | China | Maker | Dental Tools, Oral Care kit, DCK05, DCK06, DCK07, DCK08, DCK09 · Retainer Case, DSB01, DSB02, DSB03, DSB04, DSB05, DSB06, DSB07, DSB08, DSB09 | — | — |
| Spartech Instruments & Co. | Pakistan | Maker | MATRIX DENTAL | — | — |
| Melpex Beauty Instruments | Pakistan | Maker | INSTRUMENTS, DENTAL HAND | — | — |
| Shandong Hengfeng Kerui Medical Equipment Co., Ltd | China | Maker | Chewing Gum, Torque Wrench, Locator Core Tool | — | — |
| Shenzhen Sunmc Dental Technology Co., Ltd. | China | Maker | Aligner removal tool,Retainer removal tool | — | — |
| Accumedix, Inc. | United States | Maker | Flycast Technologies Dental Band · Pinkband Dental Band | — | — |
| Armatech International | Pakistan | Maker | Dental Instruments Hand | — | — |
| DongGuan Magenta Medical Equipment Co., Ltd. | China | Maker | Endodontic Probe · Macdel Periodontal Probe · 19:30 PM Periodontal Probe | — | — |
| Darleys Surgical Co. | Pakistan | Maker | INSTRUMENTS, DENTAL HAND | — | — |
| Elite Dental Lab | China | Maker | Dental Forceps · Model Trimmer Tools · Plaster Knife | — | — |
| Hazel Enterprises | Pakistan | Maker | INSTRUMENTS, DENTAL HAND (Lab Press) | — | — |
| Jordco Inc | United States | Maker | e-Dx Kit · e-Dx Refill Pack · e-Ruler | — | — |
| Surgikare | Pakistan | Maker | INSTRUMENTS, DENTAL HAND | — | — |
| T.A. Walthem & Company | Pakistan | Maker | INSTRUMENTS, DENTAL HAND | — | — |
| Washington Surgical International | Pakistan | Maker | INSTRUMENTS, DENTAL HAND (Lab Press) | — | — |
| Zhongshan Xinhe Co.,Ltd | China | Maker | Hand Driver, Lab Driver, Multi Unit Hes Driver, Torque Wrench, Locator Core Tool, Implant Drive, Chewing Gum, · Torque Wrench, Locator Core Tool | — | — |
| Ashtel Studios, Inc. | United States | Maker | Dental hand instrument | — | — |
| Hebu Medical GmbH | Germany | Maker | AND OTHERS · Instruments, Dental Hand · MATRIX WAXER · SPATULA/PACKER | — | — |
| Madina Surgical Works | Pakistan | Maker | INSTRUMENTS, DENTAL HAND | — | — |
| Hospimed Mfg | Pakistan | Maker | Instruments, Dental Hand | — | — |
| Wellmed Dental Medical Supply Co., Ltd. | China | Maker | INSTRUMENTS, DENTAL HAND | — | — |
| Emerald Instruments | Pakistan | Maker | INSTRUMENTS, DENTAL HAND | — | — |
| Guangxi Ehall Medical Technology Co.,Ltd | China | Maker | Mixing Tip, Mixing Bowl, Mixing Spatula, Mixing Gun, Mixing pad | — | — |
| Jiangsu Province Yangzhou Shuguang Toothbrush Manu | China | Maker | Aligner Tray Seater · Chewies | — | — |
| Karl Hammacher GmbH | Germany | Maker | Choking Rescue Device · Fluid Fighter Suction Mat; Suction Mat; Suction Ring; Suction Ring With Tubing; Apparatus Suction; Suction Catheter · Karl Hammacher GmbH | — | — |
| Sabri Industries | Pakistan | Maker | INSTRUMENTS, DENTAL HAND | — | — |
| Atria Co. | South Korea | Maker | Atria | — | — |
| Concise Enterprises | Pakistan | Maker | Dental Curette, Dental Forceps · Dental Tweezers, Dental Scaler, Dental Excavator · Examination Instruments, Restorative Instruments, Periodontal Instruments, Extraction Instruments | — | — |
| Mts Brothers Surgical Instruments | Pakistan | Maker | INSTRUMENTS, DENTAL HAND | — | — |
| Robinson Healthcare Limited | United Kingdom | Maker | Instrapac | — | — |
| Shenzhen Balinda Technology Co.,Ltd | China | Maker | Aligner Retainer Case/Dental Retainer Case/Orthodontic Mouthguard Case/ Denture Retainer Box | — | — |
| Tim J. Prusaitis | United States | Maker | PRU-DENT | — | — |
| Tontarra Medizintechnik GmbH | Germany | Maker | — | — | — |
| Asanus Medizintechnik GmbH | Germany | Maker | ASANUS | — | — |
| SITEC (Pvt.) Ltd. | Pakistan | Maker | Instruments, Dental Hand | — | — |
| ASA Dental | Italy | Maker | Dental Hand Instruments | — | — |
| Beijing Smart Technology Co., Ltd | China | Maker | Dental Needle · Irrigation Needle · Needle Holder · Needle Tip | — | — |
| medmix Deutschland GmbH | Germany | Maker | Endo Evacuation Needles · Endo Irrigation Needles · Flexible Steel Endo Irrigation Needles · Suction Needles | — | — |
| Power Dental USA | United States | Maker | — | — | — |
| Shanghai D-One International Co., Ltd. | China | Maker | Dental hand instrument | — | — |
| Zhejiang Headway Medical Equipment Co., Ltd. | China | Maker | micro screw driver handles · orthodontic tools · self ligating tools | — | — |
| Fetzer Medical GmbH & Co.KG | Germany | Maker | graft packer · Oral Root Teaser · Root Tip Pick | — | — |
| Libral Traders Pvt Ltd | India | Maker | Aligner Retriever, Aligner Chewies, Aligner Retainer Case, Photographic Mirrors, Elastic Placer | — | — |
| Ningbo Denrotary Medical Apparatus Co., Ltd. | China | Maker | Retainer Case | — | — |
| Peter Brasseler Holdings, LLC | United States | Maker | — | — | — |
| Chung Song Industrial Co. | South Korea | Maker | SUNBURST | — | — |
| E Hahnenkratt GmbH | Germany | Maker | HAHNENKRATT-MATRIX-BANDS | — | — |
| medmix China LTD | China | Maker | Components Dispenser 25ml,1:1 · Dispenser 25ml 1:1/2:1 · Dispenser 50ml 1:1/2:1 · Dispenser, 25ml, 1:1 · +4 | — | — |
| Quality Concept (Pvt.) Ltd. | Pakistan | Maker | INSTRUMENTS, DENTAL HAND | — | — |
| Shandong Richsource Biological Technology Co.,Ltd | China | Maker | Dental Orthodontic Bite Stick, Dental Braces Extractor | — | — |
| Empire Surgical Instruments Company | Pakistan | Maker | EMPSURG | — | — |
| Implant Logistics / AMS Micromedical | United States | Maker | — | — | — |
| Jay-Med | Pakistan | Maker | INSTRUMENTS, DENTAL HAND | — | — |
| Get-Grin Inc | United States | Maker | Get Grin Mini Scope · Get Grin Scope · Get Grin Scope 3D print version · Get Grin Scope Version 2 · +3 | — | — |
| Pesitro Healthcare Products Co., Ltd. | China | Maker | — | — | — |
| Shurcon Manufacturing Company | China | Maker | ACCS INSTRUMENTS, DENTAL HAND | — | — |
| Beijing ZKSK Technology Co., Ltd. | China | Maker | Dental Instrument Kit | — | — |
| J&J Instruments | United States | Maker | OPENING AND PLACER TOOL | — | — |
| RC Consolidated Services, Inc | United States | Maker | RCM INSTRUMENTS, DENTAL HAND · RidgeCura Medical INSTRUMENTS, DENTAL HAND | — | — |
| Dongguan Ouwen Medical Device Technology Co., Ltd. | China | Maker | Dental Composite Extruder · Dental Conveyor | — | — |
| medmix Switzerland AG | Switzerland | Maker | INSTRUMENTS, DENTAL HAND | — | — |
| Myka Sons & Co | Pakistan | Maker | INSTRUMENTS, DENTAL HAND | — | — |
| Dockum Research Lab | United States | Maker | Wizard Wedges Anatomical Matrix · Wizard Wedges Matrix | — | — |
| DongGuan TaiFeng Sporting Manufactory Co., | China | Maker | Floss Hands | — | — |
| Jiangyin Jintaike Biotech Co., Ltd. | China | Maker | INSTRUMENTS, DENTAL HAND | — | — |
| Kohler Medizintechnik GmbH | Germany | Maker | — | — | — |
| Larident SRL | Italy | Maker | DEL JECT AMALGAM GUN | — | — |
| Smile Line SA | Switzerland | Maker | Compovibes | — | — |
| Acot Plastics (Xiamen) Co., Ltd. | China | Maker | Dental Nozzle | — | — |
| DSC Dental, LLC | United States | Maker | Tofflemire | — | — |
| Jin Hsiang Enterprise Co., Ltd. | Taiwan | Maker | — | — | — |
| PUL & Co. | United States | Maker | thePulsystem · thePultool | — | — |
| Ricomed LLC | United States | Maker | — | — | — |
| Sentronic International Corp. | Taiwan | Maker | "G-Be-Bite" Dental hand instrument | — | — |
| Andre Gregate Braga Instrumentos Ltda | Brazil | Maker | Supremo Industria · Supremo Surgical | — | — |
| Calibaja Manufacturing, S.A. de C.V. | Mexico | Maker | — | — | — |
| Dr. Walser Dental GmbH | Germany | Maker | WALSER MATRIX | — | — |
| frasaco GmbH | Germany | Maker | MATRIX BANDS | — | — |
| Gebruder Renggli AG | Switzerland | Maker | Cavifil Injector | — | — |
| Nubird Inc. | United States | Maker | Nubird Suction Mirror | — | — |
| OrthoNu, LLC | United States | Maker | Tweakz for Aligners · Tweakz for Braces | — | — |
| Solmetex, LLC | United States | Maker | Instrument, dental hand | — | — |
| SUBAN Instruments Germany GmbH | Germany | Maker | RL-251-062 · WL 01-0434 | — | — |
| W.R. Rayson Co Inc | United States | Maker | Mylar Matrix Strips | — | — |
| Allure Ortho | United States | Maker | — | — | — |
| Armm, Inc. | United States | Maker | — | — | — |
| JMS Manufacturing, Inc. | United States | Maker | Bite DX | — | — |
| Mainstream Medical Devices | United States | Maker | Get-Grin | — | — |
| Precxis | France | Maker | KONTACT DENTAL IMPLANT SYSTEM | — | — |
| USTOMED INSTRUMENTE GmbH & Co. KG | Germany | Maker | — | — | — |
| Xinhua Surgical Instrument Co.,Ltd. | China | Maker | — | — | — |
| A. Milazzo Medizintechnik GmbH | Germany | Maker | — | — | — |
| Air Water Realize Inc. | Japan | Maker | — | — | — |
| Autocam Medical | United States | Maker | — | — | — |
| Avalign Technologies | United States | Maker | — | — | — |
| Berger Surgical Medical Products GmbH | Germany | Maker | — | — | — |
| Devemed GmbH | Germany | Maker | — | — | — |
| EPDENT Co., Ltd. | South Korea | Maker | — | — | — |
| Fetzer Surgical, LLC | United States | Maker | — | — | — |
| Helmut Zepf Medizintechnik GmbH | Germany | Maker | — | — | — |
| Hipp Medical AG | Germany | Maker | — | — | — |
| Jaffrose International | Pakistan | Maker | — | — | — |
| Janman Precision Industry Co Ltd | Taiwan | Maker | — | — | — |
| Max Hauser Suddeutsche Chirurgie-Mechanik GmbH | Germany | Maker | — | — | — |
| RZ Medizintechnik GmbH | Germany | Maker | — | — | — |
| Stengelin Medical | Germany | Maker | — | — | — |
| Terlain Ent., Inc. | United States | Maker | — | — | — |
| Wise Instruments | Pakistan | Maker | — | — | — |
| Voco GmbH | Germany | Foreign exporter | application cannulae | 117 | 2026 |
| Liaoning Upcera Co., Ltd | China | Contract manufacturer | Adhesive Tip Applicator · Optrastick | 10 | 2026 |
| American Orthodontics | United States | Contract manufacturer | AO Instruments - Open/Closer · AO Instruments - Scaler, Band Pusher · Band Slitting Instrument · Bracket & Band Placing Instrument (Band Pusher) · +11 | 44 | 2026 |
| Keystone Industries | United States | Contract manufacturer | Prehma Matrix Bands, Rolls & Retainers · Wonder Wedges Interproximal Wedges | 2 | 2025 |
| Myofunctional Research Co. Usa Inc. | United States | Foreign exporter | — | 3 | 2026 |
| NuSmile, Ltd. | United States | Manufacturer | NuSmile Bite Stick / Band Seater - White · NuSmile Heavy Band Pusher · NuSmile Posterior Band Remover | 2 | 2026 |
| Reliance Orthodontic Products, Inc. | United States | Contract manufacturer | Composite Filling Instrument · ReliaBox · Rely-A-Pry · Tweezers | 32 | 2021 |
| S & C Polymer GmbH | Germany | Contract manufacturer | — | 20 | 2009 |
| Biomet Microfixation | United States | Manufacturer | Seldin Root Pick | 8 | 2021 |
| Dentatus USA Ltd. | United States | Repacker / relabeler | Parmax · Profin | 4 | 2004 |
| Integra LifeSciences Corporation | United States | Contract manufacturer | Integra · Jarit · Miltex | 2 | 2014 |
| G&H Wire Company | United States | Contract manufacturer | ARMADA · EXCELSIOR · Mini-Mold · OrthoExact · +4 | 2 | 2008 |
| Hager Worldwide, Inc. | United States | Manufacturer | Del-Ject Carrier, Tips, Spring, Piston | 2 | 2005 |
| Aesculap, Inc. | United States | Lister | Aesculap | 2 | 2006 |
| George Taub Products & Fusion Co., Inc. | United States | Manufacturer | Inlay/Onlay Styx · Veneer Styx | 2 | 1986 |
| GC Orthodontics | United States | Manufacturer | TN3 | 2 | 2015 |
| Synca Marketing | Canada | Foreign exporter | Splintvac | 1 | 2010 |
| Rmo, Inc. | United States | Manufacturer | Bond Placement Tweezer / band and bracket removers; Cutters; Wire bending pliers | 1 | 1990 |
| A. Titan Instruments, Inc. | United States | Contract manufacturer | — | 1 | 2006 |
| One Dashcorp | United States | Repacker / relabeler | Valdent USA Dispensing Gun, 1:1 / 2:1 · Valdent USA Dispensing Gun, 4:1 /10:1 · Valdent USA Matrix Wooden Wedges, Assorted, Colored, 100/Pk · Valdent USA Matrix Wooden Wedges, Green, 1.5 x 2 x 14mm, 100/Pk · +10 | — | — |
| Wuxi Lyusmile Imp and Exp Co.,ltd | China | Private-label distributor | dental instrument | — | — |
| Jersey Dental Supplies | United States | Repacker / relabeler | Palodent | — | — |
| Dentimed Sao Joao LLC | United States | Repacker / relabeler | ANGELUS | — | — |
| TitanLinks Logistics LLC | United States | Repacker / relabeler | Dental instrument · Matrix Bands | — | — |
| Jmu Dental, Inc. | United States | Repacker / relabeler | Dental hand instrument | — | — |
| Patterson Companies, Inc. | United States | Foreign exporter | Patterson Instrument, Hemostat | — | — |
| Soher Med Limited | Hong Kong SAR China | Foreign exporter | Dental instrument | — | — |
| STERIS Corporation | United States | Contract sterilizer | V. Mueller Endontia Rongeur (ST-CFE) | — | — |
| Samtrade Supplies Inc. | Canada | Foreign exporter | Automatrix · Palodent Matrices | — | — |
| Summit Orthodontic Services, Inc. | United States | Repacker / relabeler | Carver · Plugger | — | — |
| Orthometric Ind. e Com. de Prod. Med. Odont. | Brazil | Manufacturer | ORTHOMETRIC INSTRUMENTAL | — | — |
| Premium Plus Dental | United States | Lister | Premium Plus Dental Hand Instruments | — | — |
| Ortho Arch Company Inc | United States | Repacker / relabeler | Elastic Attachers, Band Pusher, Band Seater | — | — |
| Great Lakes Dental Technologies, Ltd. | United States | Contract manufacturer | Aligner Removal Hook · Aligner Squeezies · Carver · EZ Key | — | — |
| Yizur Ltd | Hong Kong SAR China | Foreign exporter | Matrix Bands | — | — |
| Wise Linkers LLC | United States | Repacker / relabeler | Artman Instruments | — | — |
| CARGUS International Inc. | United States | Repacker / relabeler | MARK3® Dispensing Guns | — | — |
| LLD Care d.o.o. | Croatia | Foreign exporter | Contact Matrix · Instruments, Dental, Palodent | — | — |
| Sklar Corporation | United States | Repacker / relabeler | Dental Sets | — | — |
| AMD Medicom Inc | Canada | Foreign exporter | Medicom Pro-Matrix Band | — | — |
| First Dental Supplies LLC | United States | Repacker / relabeler | Instruments, Dental Hand | — | — |
| battech | United States | Repacker / relabeler | Mouth Props.ENDO MEASURE BLOCK.ENDO CLEAN BLOCK;ENDO Ring and Chshions; Poly Wedge;wooden wedge; Silicone Rubber Mixing | — | — |
| Maxill Inc. | United States | Foreign exporter | Dental Wedges (Wooden, Plastic with Hole, Wedge Batons) | — | — |
| Shanghai smedent medical instrument co., ltd. | China | Foreign exporter | Dappen dishes, spatulas, bite block, hand instruments · dental wedges ,matrix band, bib clips, bite wing arm | — | — |
| White Oak Orthodontic Products | United States | Repacker / relabeler | Infinity | — | — |
| Xplora USA LLC | United States | Manufacturer | Six Month Smiles | — | — |
| YCH Distripark Sdn Bhd | Malaysia | Foreign exporter | Aesculap | — | — |
| E A Beck & Company | United States | Repacker / relabeler | Beck Instrument, Dental Hand | — | — |
| Boen Healthcare Co Ltd | China | Foreign exporter | Choking Rescue Device · Fluid Fighter Suction Mat; Suction Mat; Suction Ring; Suction Ring With Tubing; Apparatus Suction; Suction Catheter · Karl Hammacher GmbH | — | — |
| US Orthodontic Products | United States | Repacker / relabeler | Dental Instrument | — | — |
| Midwest Dental | United States | Repacker / relabeler | Advance Ortho Instruments | — | — |
| Phoenix Orthodontics Inc | United States | Repacker / relabeler | Phoenix Wire Cutters · Phoenix Wire Forming Instruments | — | — |
| Sontec Instruments Inc | United States | Repacker / relabeler | Multiple | — | — |
| Shenzhen Upcera Digital Dental Technology Co., Ltd | China | Foreign exporter | Adhesive Tip Applicator; Optrastick | — | — |
| Cordica Medical (Formally Team Technologies, Inc) | United States | Contract manufacturer | — | — | — |
| K&S Instruments | United States | Repacker / relabeler | Alden Dental Hand Instruments | — | — |
| Dental Engineering Laboratories | United States | Repacker / relabeler | TFRK-GPR · TFRK-L · TFRK-L+ | — | — |
| Omnia SRL | United States | Contract manufacturer | MAXIL | — | — |
| Sanicure BV | Netherlands | Foreign exporter | — | — | — |
| Shenzhen Upcera Dental Technology Co., Ltd | China | Foreign exporter | Adhesive Tip Applicator · Optrastick | — | — |
| Zapalign LLC | United States | Repacker / relabeler | — | — | — |
| Oriental International Supplies Limited | Hong Kong SAR China | Foreign exporter | Aligner Tray Seater · Chewies | — | — |
| ambler surgical | United States | Repacker / relabeler | Ambler | — | — |
| Med Saver, Inc. | United States | Repacker / relabeler | MSI Precision Specialty Instruments | — | — |
| Tender Corporation d/b/a Adventure Ready Brands | United States | Repacker / relabeler | Dental Spatula | — | — |
| Vermont Manufacturing Services, Inc. | United States | Repacker / relabeler | Adventure Ready Brands | — | — |
| Alta Smiles, Inc | United States | Manufacturer | — | — | — |
| Boss Instruments Ltd | United States | Repacker / relabeler | — | — | — |
| Chemo Mouthpiece, LLC D/B/A Ice Cold Mouthpiece | United States | Contract manufacturer | — | — | — |
| Elmed, Inc. | United States | Repacker / relabeler | — | — | — |
| CBR Enterprise Limited | Hong Kong SAR China | Foreign exporter | INSTRUMENTS, DENTAL HAND | — | — |
| Kash Sales Inc. | Canada | Foreign exporter | — | — | — |
| MM Meder | Germany | Foreign exporter | Marlene Meder | — | — |
| Olulo LLC | United States | Repacker / relabeler | — | — | — |
| 3D Dental Designs and Development LLC | United States | Contract manufacturer | JOY Smart Matrix Bands | — | — |
| Boca Dental Regenerative, LLC. | United States | Lister | — | — | — |
| Bright Supply Inc | United States | Lister | — | — | — |
| ProNorth Medical | Canada | Foreign exporter | Dental Intruments | — | — |
| Mainline Medical Dental Supply | Canada | Foreign exporter | — | — | — |
| Oketz Logistics LLC | United States | Repacker / relabeler | — | — | — |
| Premier Online Exodontia Courses, Inc. | Canada | Foreign exporter | — | — | — |
| Transin Biomedical Co., Ltd. | Taiwan | Foreign exporter | — | — | — |
| Wise Instruments Inc | United States | Repacker / relabeler | — | — | — |
| Xlent Global Inc | United States | Repacker / relabeler | — | — | — |
| Zircon Plus Limited | Israel | Foreign exporter | — | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 25 Jul 2012 | K111465 | COMPOTHIXO | Kerrhawe SA |
| 31 Aug 2007 | K071858 | DENTAL MATRIX BAND | Fly Cast Technologies, Inc. |
| 22 Jun 1990 | K901919 | CONTACT MOLAR BANDS AND CONTOUR STRIPS | Ivoclar North America, Inc. |
| 12 May 1986 | K861581 | CENTRIX PCR MOLAR MATRIX FORMS (BANDS) | Centrix, Inc. |
| 3 Dec 1984 | K844324 | TIGER BAND | World Wide Outdoor Marketing |
| 13 Apr 1984 | K840984 | INTERDENTAL WEDGES | Healthco, Inc. |
| 16 Aug 1982 | K822094 | DENTAL MATRIX BAND | Dentsply Intl., Inc. |
| 14 Jun 1982 | K821444 | COLORED WEDGE USED TO SEPARATE TEETH | Moyco Industries, Inc. |
| 7 Aug 1980 | K801142 | PALODENT MATRICES & BITINE RINGS | Alvin Meyer, D.D.S. |
| 28 Jul 1980 | K801530 | COREFORM MOLDS | Sybron Corp. |
| 17 Jan 1980 | K790555 | HEMO-WEDGE | Parker Laboratories, Inc. |
| 21 May 1979 | K790600 | HOWMEDICA STRIP CROWN | Howmedica Corp. |
| 21 May 1979 | K790599 | RUWA MATRIX STRIPS | Howmedica Corp. |
| 17 May 1979 | K790633 | ACCOR MATRIX | Accor, Inc. |
| 3 Jan 1978 | K772316 | MATRIX STRIP, DEAD-SOFT | Den-Mat Corp. |
| 3 Jan 1978 | K772314 | WEDGES, RETAINING, MATRIX | Den-Mat Corp. |
Official records: FDA product classification for DZN · 21 CFR 872.4565.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026