Surgical devices · 21 CFR 872 Subpart E
Orthodontic Plier
FDA device type “Plier, Orthodontic”.
- Companies listing it
- 218161 makers
- Brands and models
- 643
- 510(k) clearances
- 70 in five years
- FDA name
- Plier, Orthodontic
510(k) clearances per year, 1976–2026
Companies that list JEX
218 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Align Technology, Inc. | United States | Maker | Invisalign Detail Pliers · Invisalign Eraser Pliers · Invisalign Pliers Set (Detail/Eraser) | 16 | 2026 |
| Sybron Dental Specialties | United States | Maker | — | 203 | 2026 |
| KLS Martin SE & Co. KG | Germany | Maker | — | 43 | 2026 |
| Den-Mat Holdings, LLC | United States | Maker | LUMIGrip | 8 | 2026 |
| Ortho Organizers, Inc. | United States | Maker | BAND REMOVER · BRACKET PLACEMENT/POSITIONER · BRACKET REMOVER · Carriere Double Ended Opener Tool · +11 | 8 | 2025 |
| Tp Orthodontics, Inc. | United States | Maker | ORTHODONTIC PLIERS | 5 | 2022 |
| Leone S.P.A. | Italy | Maker | Orthodontic pliers and instruments | 4 | 2025 |
| Mem Dental Technology Co., Ltd. | Taiwan | Maker | — | 2 | 2025 |
| Shenzhen Rogin Medical Co., Ltd. | China | Maker | Orthodontic Pliers | 1 | 2025 |
| Kids-E-Dental LLP | India | Maker | e- crimper · e-Cutter | 1 | 2024 |
| Medicon EG | Germany | Maker | — | 9 | 2005 |
| Hu-Friedy Mfg Co., LLC | United States | Maker | Hu-Friedy Mfg Co.,LLC | 8 | 2012 |
| Forestadent Bernhard Forster GmbH | Germany | Maker | Orthodontic Pliers and Instruments | 4 | 2011 |
| GNI Co., LTD | South Korea | Maker | PLIER | 3 | 2021 |
| Dentos, Inc. | South Korea | Maker | AMPLC (Angled Mini-Pin Ligature Cutter) · APLC (Angled Pin & Ligature Cutter) · AT (Arch wire Tucker) · BBP (Bird Beak Plier) · +36 | 2 | 2019 |
| Integra LifeSciences Corporation | United States | Maker | Jarit · Miltex | 2 | 2014 |
| Storz AM Mark GmbH | Germany | Maker | Wire forceps, Rubber ring removing forceps, Flat pliers, Round pliers, Pin bending pliers, Wire bending pliers | 2 | 2008 |
| DB Orthodontics Limited | United Kingdom | Maker | — | 2 | 2010 |
| GC Orthodontics | United States | Maker | — | 2 | 2015 |
| World Bio Tech Co Ltd | South Korea | Maker | Orthodontic Pliers ; Cutters, Utility Pliers, Removing Pliers, Wire Bending Pliers, Tweezers, ETC | 2 | 2016 |
| Clearpath Orthodontics | Pakistan | Maker | Defence Dental Center | 2 | 2021 |
| Dental Morelli | Brazil | Maker | — | 2 | 2014 |
| HT Co., Ltd. | South Korea | Maker | MISO DEBONDING PLIER HT-001 | 1 | 2011 |
| Osung Mnd Co Ltd | South Korea | Maker | BOS-OPK · OPAP01 · OPAP02 · OPAP03 · +25 | — | — |
| Hespeler Orthodontics Ltd | Canada | Maker | AWHPLIER · HGHP-02 · HGHP-02K · HGHP-02R · +1 | — | — |
| ErgoDenta ApS | Denmark | Maker | Adams Plier, max 0.4mm, Lap joint, 13cm · Aderer Plier, Long. max 0.6mm, 13cm · Aderer Plier, Short. max 0.6mm, 11.5cm · Adhesive Removal Plier · +38 | — | — |
| Zain's Medical Image | Pakistan | Maker | Adhesive Removing Pliers · Badee Crown Removing Plier · Band Removing Plier · Bird Beak Plier · +65 | — | — |
| Densol International (Private) Limited | Pakistan | Maker | Aderer 3 Jaw Pliers · Aligner Horizontal Window Pliers · Aligner Punch Hole Pliers 3mm · Aligner Punch Hole Pliers 4.5mm · +34 | — | — |
| Metro Medical | Pakistan | Maker | Dental Pliers For Nerve Needle, 6", 15 cm · Dental Pliers For Nerve Needle, 61/2", 16.5 cm · Dental Pliers For Nerve Needle, 61/8", 15.5 cm · Dental Pliers, College, 53/4", 14.5 cm · +16 | — | — |
| Schobell Industrial Ltda | Brazil | Maker | Angles Pliers · Arch forming pliers (De La Rosa) · Band resin removing pliers, TC · Band resin removing pliers, TC, long · +33 | — | — |
| Shanghai Kangqiao Dental Instruments Factory | China | Maker | Arch turret no gauge I/II · Arch turret with gauge I/II · Braces tweezers 1# 11cm/2# 12.5cm/3# 12.5cm/4# 13cm/5# 14cm · Bracket instrument KT5/TJZ1 · +12 | — | — |
| Dentaurum GmbH & Co. KG | Germany | Maker | Contouring pliers · Crimping pliers · How pliers · Ligature Forming pliers · +5 | — | — |
| 株式会社ＹＤＭ | Japan | Maker | Adams Pliers Universal T/C · Convertible Cap Removing Pliers ND-934 · Distal End Cutter EVER Fine 606L T/C · Distal End Cutter EVER Fine 606S T/C · +60 | — | — |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | China | Maker | Orthodontic pliers | — | — |
| B. Ali Impex | Pakistan | Maker | BALI · DOCTOR NICE | — | — |
| Shenzhen Denco Medical Co Ltd | China | Maker | Orthodontic Pliers | — | — |
| Bashir Jamil & Bros. (Pvt.), Ltd. | Pakistan | Maker | STAINLESS PLIERS # 110 · STAINLESS PLIERS # 114 · STAINLESS PLIERS # 118 · STAINLESS PLIERS # 121 · +3 | — | — |
| Aspen Surgical Products | United States | Maker | Symmetry Surgical | — | — |
| Technimen Skillers | Pakistan | Maker | COON · Elastic Clamps · Elastic Pliers · JOHNSON, REYNOLDS, HOW, PEESO, ABELL, GOSLEE,GORDON, BIRD BEAK · +3 | — | — |
| Falcon Surgical Co. (Pvt.) Ltd. | Pakistan | Maker | Pliers | — | — |
| Pomee Corporation | Pakistan | Maker | Anterior Bracket Placer · BAnd Pusher · Band Seating Plier · Bracket Removing Pliers · +11 | — | — |
| Commic Surgico | Pakistan | Maker | Distal End Cutter, Pliers · Orthpdontic Lab Pliers · Wire Bending Pliers · Wire Cutter Pliers | — | — |
| Endo Tech Instruments | Pakistan | Maker | Orthodontic Pliers | — | — |
| Medcave Private Limited | Pakistan | Maker | Orthodontic Plier | — | — |
| Panorama International | Pakistan | Maker | PLIER, ORTHODONTIC | — | — |
| Shanghai Dochem Industries Co., Ltd. | China | Maker | Single use dental tweezer | — | — |
| Accompany Surgical | Pakistan | Maker | JOHNSON, REYNOLDS, HOW, PEESO, ABELL, GOSLEE,GORDON, BIRD BEAK, ETC | — | — |
| Lacigrus International | Pakistan | Maker | PLIER, ORTHODONTIC | — | — |
| Comfort Surgical Instruments | Pakistan | Maker | Orthodontic Plier | — | — |
| Aesculap AG | Germany | Maker | ORTHODONTIC PLIER | — | — |
| Adolf Schweick Hardt GmbH & Co | Germany | Maker | ORTHODONTIC PLIERS | — | — |
| Hangzhou Westlake Biomaterial Co., Ltd. | China | Maker | Plier, Orthodontic · Plier, Orthodontic (All types of orthodontic pliers) · XIHUBIOM | — | — |
| Confident Instruments | Pakistan | Maker | Artman Instruments | — | — |
| Denta Craft Instruments | Pakistan | Maker | JOHNSON, REYNOLDS, HOW, PEESO, ABELL, GOSLEE,GORDON, BIRD BEAK, ETC | — | — |
| Hangzhou Orthmay Advanced Materials Technology Co., Ltd | China | Maker | Orthodontic Plier | — | — |
| Hilbro Instruments (Pvt) Ltd | Pakistan | Maker | HILBRO INSTRUMENTS · PLIER, ORTHODONTIC | — | — |
| Medisporex Private Limited | Pakistan | Maker | MEDIS | — | — |
| Otto Leibinger GmbH | Germany | Maker | Orthodontic Plier | — | — |
| OSSTEM ORTHODONTICS Inc. | South Korea | Maker | Step Bend Plier L · Step Bend Plier R | — | — |
| Solventum US LLC | United States | Maker | Prestige · Unitek | — | — |
| Dentag SRL | Italy | Maker | DENTAG | — | — |
| Acme Enterprises | Pakistan | Maker | Orthodontic Pliers · TBS Dental | — | — |
| Surgicrafts | Pakistan | Maker | JEX / PLIER, ORTHODONTIC | — | — |
| Orthodontic Manufacturer SIA SRL | Italy | Maker | SIA ORTHODONTIC MANUFACTURER | — | — |
| Acheron Instruments (Pvt.) Ltd. | Pakistan | Maker | Flat Nose Plier | — | — |
| Harf Industries | Pakistan | Maker | Crown Crimping,Distal End Cutter,Pin & Ligature, Band Removing, How plier, | — | — |
| Innovative Material And Devices, Inc. | China | Maker | Adams Pliers, Distal End Cutters, Flush Cutters, Distal End Cutters, Mini Ligature & Pin Cutters, Ligature & Pin Cutters · Bonding Tweezers, Mathieu Needle Holder, Schure Band Seater, Mershon Band Pusher, Ligature Director, · Cap Removing Pliers, Vertical Slot Forming Pliers, Horizontal Slot Forming Pliers, Tear Drop Thermal Forming Pliers, · Hole Punch Thermal Forming Pliers, Distal End Cutters, Articulating Paper Holding Tweezers · +8 | — | — |
| Silver Plus Corp. | Pakistan | Maker | PLIER, ORTHODONTIC | — | — |
| Shanghai Medical Instruments (Group) Ltd. Corp. | China | Maker | ORTHODONTIC PLIER | — | — |
| Surgiscape | Pakistan | Maker | PLIER, ORTHODONTIC | — | — |
| Maryam Trading | Pakistan | Maker | MARYAM TRADING · Multi · PLIER, ORTHODONTIC | — | — |
| Garana Industries (PVT) Ltd | Pakistan | Maker | Adhesive Removing Pliers · Posterior Brand Removing Pliers Short · Three Prong Pliers · Tube Crimping Pliers · +3 | — | — |
| Towne Brothers (Pvt) Ltd | Pakistan | Maker | PLIER, ORTHODONTIC | — | — |
| Zhejiang Protect Medical Equipment Co. Ltd. | China | Maker | Eurodonto · protect | — | — |
| Biopsy Fine Cut Instruments | Pakistan | Maker | PLIER, | — | — |
| Choose Surgical Instruments | Pakistan | Maker | PLIER, ORTHODONTIC | — | — |
| Lohar Medical Company | Pakistan | Maker | JEX / PLIER, ORTHODONTIC | — | — |
| Acme Commercial Ways Ltd. | Pakistan | Maker | PLIER, ORTHODONTIC | — | — |
| Medline Industries, LP | United States | Maker | Medline/Konig Orthodontic Plier | — | — |
| Nadir & Co. | Pakistan | Maker | Band Removing Pliers · Bird Beak Pliers · Bracket Removing Pliers · Bracket Removing Pliers Cvd · +4 | — | — |
| Y. Z. Corporation | Pakistan | Maker | YZ Orthodontic Pliers | — | — |
| Astar Orthodontics Inc | China | Maker | ligature cutter, bird beak pliers, Omega loop forming pliers, Tweed loop forming pliers, turret, End cutter | — | — |
| Daddy D Pro | Pakistan | Maker | PLIER, ORTHODONTIC | — | — |
| Mount Blonck Trading | Pakistan | Maker | PLIER, ORTHODONTIC | — | — |
| Nopa Instruments Medizintechnik GmbH | Germany | Maker | PLIER | — | — |
| Surjex | Pakistan | Maker | PLIERS, ORTHODONTIC | — | — |
| Dimeda Instrumente GmbH | Germany | Maker | DIMEDA | — | — |
| Pilotis Tech LLC | United States | Maker | Intrace USA | — | — |
| HILBRO International (Pvt) Ltd. | Pakistan | Maker | PLIER, ORTHODONTIC | — | — |
| Meed Skills Surgical | Pakistan | Maker | Meed Skills Surgical | — | — |
| Hangzhou Wise Medical Device Co.,Ltd | China | Maker | Orthodontic Plier | — | — |
| Volgo Care International (Private) Limited | Pakistan | Maker | VOLGOCARE | — | — |
| Zhejiang Yamei Medical Equipment Technology Co., Ltd. | China | Maker | — | — | — |
| SGS Export Intl. | Pakistan | Maker | Pliers, Orthodontic | — | — |
| Med2B Ltd. | Germany | Maker | PLIER, ORTHODONTIC | — | — |
| Melpex Beauty Instruments | Pakistan | Maker | PLIER, ORTHODONTIC | — | — |
| Armatech International | Pakistan | Maker | Bird Beak Pliers, Band Removing Pliers, Countering Pliers, Crimping Pliers, Detailing Pliers · Hook Bracket Pliers, How Pliers, Loop Forming Pliers, Utility Pleirs, Weingart Pliers | — | — |
| Central Surgical Co. Pvt. Ltd. | Pakistan | Maker | PLIER, ORTHODONTIC, PLIERS OF ALL TYPES | — | — |
| Aesculap Chifa SP. Z O.O. | Poland | Maker | PLIER, ORTHODONTIC | — | — |
| Changsha Nice Medical Instrument Limited Company | China | Maker | Niceortho PLIER, ORTHODONTIC | — | — |
| Diligent Medical Ser | Pakistan | Maker | PLIER, ORTHODONTIC | — | — |
| Hebu Medical GmbH | Germany | Maker | Plier, Orthodontic | — | — |
| Wuhu Guli Ortho Co.,Ltd | China | Maker | Orthodontic plier | — | — |
| Alvi Expo | Pakistan | Maker | PLIER, ORTHODONTIC | — | — |
| Hexamed Pvt Ltd | Pakistan | Maker | Dental Orthodontic Plier | — | — |
| Nawaz and Sons | Pakistan | Maker | JEX / PLIER, ORTHODONTIC | — | — |
| Richbolt Enterprises | Pakistan | Maker | PLIERS ORTHODONTIC | — | — |
| Emerald Instruments | Pakistan | Maker | PLIER, ORTHODONTIC | — | — |
| Ghousia Amanat Surgical | Pakistan | Maker | Dental Plier With Inserted Tip · Dental Pliers | — | — |
| Guangzhou Cheer-U Material Technology Co., Ltd | China | Maker | Orthodontic Plier | — | — |
| Guangzhou OO Medical Scientific Limited | China | Maker | OO Dental | — | — |
| Karl Hammacher GmbH | Germany | Maker | Karl Hammacher GmbH | — | — |
| Tontarra Medizintechnik GmbH | Germany | Maker | Plier | — | — |
| Professional Surgical Instruments Co., Inc. | United States | Maker | MD1 Mead Extraction Forceps · Upper Root Tip Extraction Forceps · 150 Universal Extraction Forceps, Serrated · 151 Universal Extraction Forceps, Serrated · +6 | — | — |
| Ameda Instruments Company | Pakistan | Maker | Bracket Removing Angled · Step Pliers | — | — |
| ASA Dental | Italy | Maker | Orthodontic Plier | — | — |
| Power Dental USA | United States | Maker | — | — | — |
| Trinity Sterile Inc | United States | Maker | Plier | — | — |
| Avilign Medical | Pakistan | Maker | PLIER, ORTHODONTIC | — | — |
| Garnet Dentech | South Korea | Maker | ORTHODONTIC PLIERS | — | — |
| Greens Surgicals Private Limited | India | Maker | GREENS | — | — |
| Hangzhou Angsheng Orthodontic Products Co. Ltd | China | Maker | Plier, Orthodontic | — | — |
| Universal Orthodontic Lab, Inc. | United States | Maker | Pliers | — | — |
| Zhejiang Eksen Medical Technology Co., Ltd | China | Maker | Orthodontic Plier | — | — |
| Zhejiang Shinye Medical Technology Corp.,Ltd | China | Maker | Plier | — | — |
| American Angle Ortho, LLC | United States | Maker | Pliers orthodontics | — | — |
| Funing Meitedental Factory | China | Maker | Orthodontic pliers | — | — |
| Hangzhou DTC Medical Apparatus Co., Ltd | China | Maker | Metal Pliers;DTC;Orthodontics | — | — |
| Zhejiang YO Medical Technology Co., Ltd | China | Maker | DENTMAS; GLOBAL DENTAL; Orthodontics; TEXDENT | — | — |
| GSource LLC | United States | Maker | Universal Pliers | — | — |
| Hangzhou PengWu Medical Equipment Co.,Ltd | China | Maker | SmileStreamSolutions / PW Ortho | — | — |
| Weldon Instruments | Pakistan | Maker | JEX / PLIER, ORTHODONTIC | — | — |
| Univy Technology Advanced Co. Ltd | China | Maker | Orthodontic Plier | — | — |
| Sobytek Instruments Co. | Pakistan | Maker | Pliers | — | — |
| Creative Dental | China | Maker | Plier | — | — |
| Cynosure LLC | United States | Maker | NON-SLIP GRIP TIP PLIERS | — | — |
| J&J Instruments | United States | Maker | — | — | — |
| Magnum Medical | United States | Maker | Orthodontic Pliers | — | — |
| Precision Beauty & Dental Instruments LLC | United States | Maker | Precision Dental Instruments | — | — |
| Hilbro Pvt Ltd | Pakistan | Maker | PLIER, ORTHODONTIC | — | — |
| Myka Sons & Co | Pakistan | Maker | Pliers | — | — |
| QSA Surgical | Pakistan | Maker | ORTHODONTIC (MULTIPLE BRANDS) | — | — |
| Shioda Dental Co. | Japan | Maker | SHIODA · TASK | — | — |
| IAA Surgical Instruments Co | Pakistan | Maker | Plier | — | — |
| Kohler Medizintechnik GmbH | Germany | Maker | — | — | — |
| Orthguide Medical Technology (jiangsu) Co., Ltd | China | Maker | — | — | — |
| STONE Instruments company | Pakistan | Maker | PLIER, ORTHODONTIC | — | — |
| Flavio Medicos | Pakistan | Maker | Pliers | — | — |
| Orthopli Corp. | United States | Maker | VARIOUS ORTHODONTIC PLIERS | — | — |
| SUBAN Instruments Germany GmbH | Germany | Maker | — | — | — |
| Phoenix Instruments, Inc. | United States | Maker | — | — | — |
| Devemed GmbH | Germany | Maker | — | — | — |
| Elmed Instruments (Pvt) Ltd | Pakistan | Maker | — | — | — |
| Faulhaber Pinzetten KG | Germany | Maker | — | — | — |
| Geomed Medizin-Technik GmbH & Co | Germany | Maker | — | — | — |
| Gulmag International | Pakistan | Maker | — | — | — |
| Helmut Zepf Medizintechnik GmbH | Germany | Maker | — | — | — |
| Nextcon International | Pakistan | Maker | — | — | — |
| Sinntech Medical (Private) Limited | Pakistan | Maker | — | — | — |
| SMT Schilling Metalltechnik GMBH | Germany | Maker | — | — | — |
| Wise Instruments | Pakistan | Maker | — | — | — |
| Meta Biomed Co, Ltd | United States | Manufacturer | — | 24 | 2024 |
| American Orthodontics | United States | Contract manufacturer | Luno (Cutters, Band Remover) · Luno (Pliers) · Wire Bending Pliers | 44 | 2026 |
| Young Innovations Inc | United States | Contract manufacturer | — | 23 | 2025 |
| NuSmile, Ltd. | United States | Manufacturer | NuSmile 3 Jaw Plier · NuSmile Band / Crown Crimping Plier · NuSmile Bird Beak Plier · NuSmile Contouring Plier · +1 | 2 | 2026 |
| G&H Wire Company | United States | Contract manufacturer | ARMADA · EXCELSIOR · PARAGON | 2 | 2008 |
| Aesculap, Inc. | United States | Lister | Aesculap | 2 | 2006 |
| Rmo, Inc. | United States | Manufacturer | Schweickhardt/Apex Series Pliers | 1 | 1990 |
| One Dashcorp | United States | Repacker / relabeler | Valdent USA #317 Stainless Steel College Plier · Valdent USA #318 Stainless Steel Meriam Plier · Valdent USA Stainless Steel Crown and Band Contouring Plier, 1/Pk. | — | — |
| Five Star Orthodontic Laboratory & Supply, Inc. | United States | Contract manufacturer | Various Orthodontic Pliers | — | — |
| Dentimed Sao Joao LLC | United States | Repacker / relabeler | ANGELUS | — | — |
| TitanLinks Logistics LLC | United States | Repacker / relabeler | Plier | — | — |
| Jmu Dental, Inc. | United States | Repacker / relabeler | PLIER, ORTHODONTIC | — | — |
| Patterson Companies, Inc. | United States | Foreign exporter | Patterson® Safety Shear and Hold Distal End | — | — |
| Ortho Pro Dent LLC | United States | Repacker / relabeler | angle plier, bird beak plier , three prong plier , jaraback plier , torquing plier male and female · distal end cutter safety , distal end cutter long handle , dista end flush cutter · Max Plier,Orthodontic Pliers , Dista end cutter , hard wire cutter , ligature pin cutters · weingart plier , cinch back plier , Tweezer , bracket posioner , bracket holder , Tube holder | — | — |
| Soher Med Limited | Hong Kong SAR China | Foreign exporter | Plier | — | — |
| Cislak Manufacturing, Inc. | United States | Contract manufacturer | Cislak · Zoll Dental | — | — |
| Orthometric Ind. e Com. de Prod. Med. Odont. | Brazil | Manufacturer | ORTHOMETRIC PLIER | — | — |
| International Orthodontics Services. PC | United States | Repacker / relabeler | Brilliant Pliers | — | — |
| Nordent MFG., Inc. | United States | Contract manufacturer | Nordent | — | — |
| Ortho Arch Company Inc | United States | Repacker / relabeler | SLB Easy Opening Instrument | — | — |
| Csy International LLC | United States | Repacker / relabeler | J&J Ortho · J&J Orthodontics | — | — |
| PDT Inc. | United States | Contract manufacturer | — | — | — |
| Forestadent Usa | United States | Repacker / relabeler | Classic Instruments · Expression Instruments · Premier Instruments | — | — |
| TBS Dental | United States | Repacker / relabeler | TBS INOX USA | — | — |
| Wise Linkers LLC | United States | Repacker / relabeler | Artman Instruments | — | — |
| Sklar Corporation | United States | Repacker / relabeler | Plier | — | — |
| First Dental Supplies LLC | United States | Repacker / relabeler | Plier, Orthodontic | — | — |
| ArtCraft Dental, Inc. | United States | Repacker / relabeler | V-Plier | — | — |
| Ortho Solutions LC | United States | Contract manufacturer | — | — | — |
| White Oak Orthodontic Products | United States | Repacker / relabeler | Infinity | — | — |
| Xplora USA LLC | United States | Manufacturer | Six Month Smiles | — | — |
| E A Beck & Company | United States | Repacker / relabeler | PLIER, ORTHODONTIC | — | — |
| US Orthodontic Products | United States | Repacker / relabeler | Orthodontic Plier | — | — |
| Fairfield Orthodontics, LLC | United States | Repacker / relabeler | PERFORMA INSTRUMENTS | — | — |
| Orthone INC. | United States | Repacker / relabeler | orthone | — | — |
| Peak Implements Inc | United States | Repacker / relabeler | PLIER, ORTHODONTIC | — | — |
| Peter Brasseler Holdings, LLC | United States | Contract manufacturer | — | — | — |
| Mirabay Orthodontics Corporation | United States | Repacker / relabeler | MIRABAY INSTRUMENTS | — | — |
| Alta Smiles, Inc | United States | Manufacturer | — | — | — |
| Chemo Mouthpiece, LLC D/B/A Ice Cold Mouthpiece | United States | Contract manufacturer | — | — | — |
| Head Dental Corp. | United States | Repacker / relabeler | ORTHODONTIC PLIERS | — | — |
| JM Ortho Corporation | Japan | Foreign exporter | — | — | — |
| Novo Surgical Inc. | United States | Repacker / relabeler | — | — | — |
| Diversity Corporation FZE | United Arab Emirates | Foreign exporter | Plier | — | — |
| My Medical Store LLC | United States | Repacker / relabeler | PLIER, ORTHODONTIC | — | — |
| Orthodentalusa Corp. | United States | Repacker / relabeler | — | — | — |
| Surgix Medical, L.L.C. | United States | Repacker / relabeler | Pliers, Ortho | — | — |
| Olulo LLC | United States | Repacker / relabeler | — | — | — |
| Allure Ortho | United States | Repacker / relabeler | — | — | — |
| Avalign Technologies | United States | Contract manufacturer | — | — | — |
| Baeramed Instrumente | Germany | Contract manufacturer | — | — | — |
| DentOrtho LLC | United States | Repacker / relabeler | — | — | — |
| Mainline Medical Dental Supply | Canada | Foreign exporter | — | — | — |
| Oketz Logistics LLC | United States | Repacker / relabeler | — | — | — |
| Tekno-Medical Optik-Chirurgie GmbH | Germany | Manufacturer | — | — | — |
| Vehu Medical Instrumente GmbH | Germany | Repacker / relabeler | — | — | — |
| Wise Instruments Inc | United States | Repacker / relabeler | — | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 1 Dec 1995 | K955242 | TITANIUM BIRD BEAK PLIER | Sybron Dental Specialties |
| 31 Jan 1994 | K935141 | DENTAURUM PLIERS | Dentauraum, Inc. |
| 25 Nov 1992 | K924645 | TRANSCEND SERIES 6000 DEBONDING INSTRUMENTS | Unitek Corp. |
| 23 Nov 1992 | K924295 | DEBRACKETING INSTRUMENT | Unitek Corp. |
| 26 Nov 1985 | K854088 | UNITEK LIFT-OFF DEBRACKETING INSTRUMENT | Unitex Corp. |
| 9 Nov 1984 | K843742 | UNITEK CONVERTIBLE CAP REMOVER TOOL | Unitek Corp. |
| 15 Nov 1976 | K760984 | ORTHODONTIC INSTRUMENTS | Adp Intl., Inc. |
Official records: FDA product classification for JEX · 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