Surgical devices · 21 CFR 872 Subpart E
Periodontic Scaler
FDA device type “Scaler, Periodontic”.
- Companies listing it
- 212170 makers
- Brands and models
- 976
- 510(k) clearances
- 50 in five years
- FDA name
- Scaler, Periodontic
510(k) clearances per year, 1976–2026
Companies that list EMN
212 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Osstem Implant Co., Ltd. | South Korea | Maker | Metal Scaler | 68 | 2026 |
| KLS Martin SE & Co. KG | Germany | Maker | — | 43 | 2026 |
| Inter-Med, Inc. | United States | Maker | Tip Wrench · Vista #31 Special Periodontal Tip · Vista #33 L Special Periodontal Tip · Vista #33 R Special Periodontal Tip · +20 | 7 | 2026 |
| Premier Dental Products Company | United States | Maker | Premier | 28 | 2026 |
| Young Innovations Inc | United States | Maker | AEI Blackjack (XP) · AEI Montana Value · AEI Quik Tips · AEI Talon Tough · +1 | 23 | 2025 |
| Dentalez, Inc. | United States | Maker | Hand Instruments - Scalers | 9 | 2026 |
| Pac-Dent Inc. | United States | Maker | — | 5 | 2022 |
| Lakong Medical Devices Co., Ltd. | China | Maker | Perio Scaler, dental | 2 | 2026 |
| Shenzhen Micro Electric Intelligence Co., Ltd. | China | Maker | Dental calculus remover;with LED Light & 5 Modes, Rechargeable Dental Cleaner, · Plaque Remover for Teeth,Dental Cleaning Kit Tartar Remover for Teeth,UItrasonic Electric Dental Scaler · 4 Replaceable Heads,WD-JY-W001 | 1 | 2024 |
| Hu-Friedy Mfg Co., LLC | United States | Maker | Hu-Friedy Mfg Co.,LLC | 8 | 2012 |
| Storz AM Mark GmbH | Germany | Maker | color-stick scaler · Scaler | 2 | 2008 |
| Sunstar Americas, Inc. | United States | Maker | GUM Oral Care Cleaning Kit (SCALER, PERIODONTIC) | 2 | 2013 |
| Ranir, LLC | United States | Maker | — | 2 | 2011 |
| Zhengzhou Huaer Electro-optics Technology Co., Ltd. | China | Maker | Teeth Cleaning Kit | 1 | 2020 |
| Arnold Tuber Industries | United States | Maker | Scaler | 1 | 2009 |
| Osung Mnd Co Ltd | South Korea | Maker | CGR1-2 · CGR11-12 · CGR13-14 · CGR15-16 · +97 | — | — |
| ErgoDenta ApS | Denmark | Maker | Crane-Kaplan · Furcator Scaler · Hoe Scaler, Anterior · Hoe Scaler, Lateral · +64 | — | — |
| Zain's Medical Image | Pakistan | Maker | Amalagam Carver · Amalagam Plugger · Chord Packing Instruments · Columbia Scaler · +19 | — | — |
| Densol International (Private) Limited | Pakistan | Maker | Anterior Scaler Nebraska DE HH 10mm · Anterior Scaler NV1 DE HH 10mm · Anterior Scaler Remington 3/4 HH 10mm · Anterior Scaler Towner Jacquette U15/33 HH 10mm · +10 | — | — |
| Metro Medical | Pakistan | Maker | Awls, Langenbeck, Large · Awls, Langenbeck, Medium · Awls, Langenbeck, Small · Awls, Obwegeser, 14 cm · +115 | — | — |
| Schobell Industrial Ltda | Brazil | Maker | Curette PL n. 3/4 · Curette PL n. 5-6 · Curette PL n.1-2 · Extractor Mc Call n. 1-10 · +12 | — | — |
| Signor Seven International | Pakistan | Maker | Acorn Burnisher 10 mm SKU 11-687-H · Acorn Burnisher 10 mm SKU 11-687-P · Ball Burnisher 25/26 6 mm Handle SKU 11-256 · Ball Burnisher 26/27 S 6 mm Handle SKU 11-684-S · +124 | — | — |
| Shanghai Kangqiao Dental Instruments Factory | China | Maker | Gingival cord packers KGCPCSI-1/170/174/ KGCPCSI-1 A (No Serration)/ 170A(No Serration) · Gingival Separator F1/F2/E6/R6/KPT1/KPT2 · Gingival Separator KGS7/KGS8/KGS9 · Gingival Separator KPPR3 · +10 | — | — |
| Guilin Yikeshi Medical Instrument Co Ltd | China | Maker | xp-31 · xp-33 · xp-33L · xp-33R · +49 | — | — |
| 株式会社ＹＤＭ | Japan | Maker | GP Remover Spear 0.3L · GP Remover Spear 0.3S · GP Remover Spear 0.5L · GP Remover Spear 0.5S · +2 | — | — |
| Guilin Veirun Medical Technology Co., Ltd. | China | Maker | Ultrasonic Scaler Tips · Ultrasonic Scaler Tips E1 · Ultrasonic Scaler Tips E10 · Ultrasonic Scaler Tips E10D · +185 | — | — |
| B. Ali Impex | Pakistan | Maker | BALI · DOCTOR NICE | — | — |
| Prodont-Holliger | France | Maker | H5-L5 reference 4065SI - instr.dble H5-L5 Bliss · H6-H7 reference 4067SI -instr. dble H6-H7 bliss · M23 - reference 404.23SI -scaler M23 Bliss · MICRO CK6 COURBE BLISS- 4045SI · +2 | — | — |
| Dental Studio | South Korea | Maker | Sickle Scalers | — | — |
| Aspen Surgical Products | United States | Maker | Symmetry Surgical | — | — |
| Technimen Skillers | Pakistan | Maker | dental scaler | — | — |
| Cislak Manufacturing, Inc. | United States | Maker | Cislak · Zoll Dental | — | — |
| Falcon Surgical Co. (Pvt.) Ltd. | Pakistan | Maker | Scaler, Periodontic | — | — |
| Commic Surgico | Pakistan | Maker | Carver Hollenback H3 · CURVED SICKLE SCALAR · Examination kit - Probe, mirror, tweezer · Explorer · +8 | — | — |
| Endo Tech Instruments | Pakistan | Maker | JACQUETTE POSTERIOR SCALER #2-3 STANDARD HANDLE DOUBLE END 5 x 1mm BLADE · JACQUETTE SCALER #2S-3SL STANDARD HANDLE DOUBLE ENDED BLADES · JACQUETTE/SICKLE SCALER #1S-N5 STANDARD HANDLE SMALL STRAIGHT 0.9mm/MEDIUM 0.9mmBLADE · POSTERIOR SCALETTE #N135 LIGHT HANDLE DOUBLE END THIN 0.8mm BLADES 12mm REACH · +2 | — | — |
| Medcave Private Limited | Pakistan | Maker | Scalers | — | — |
| Panorama International | Pakistan | Maker | SCALER, PERIODONTIC | — | — |
| Accompany Surgical | Pakistan | Maker | SCALERS | — | — |
| Lacigrus International | Pakistan | Maker | SCALER, PERIODONTIC | — | — |
| Comfort Surgical Instruments | Pakistan | Maker | scaler | — | — |
| Aesculap AG | Germany | Maker | PERIODONTIC SCALER | — | — |
| PDT Inc. | United States | Maker | PDT, Inc. | — | — |
| Adolf Schweick Hardt GmbH & Co | Germany | Maker | SCALER, PERIODONTIC | — | — |
| Beyes Dental Inc | Canada | Maker | Beyes Scalers | — | — |
| Confident Instruments | Pakistan | Maker | Artman Instruments | — | — |
| Tangshan Zhengtong Exhibition Co., Ltd. | China | Maker | Carbon Fiber Implant Scaler Kits · Scaler kits | — | — |
| Denta Craft Instruments | Pakistan | Maker | SCALERS | — | — |
| Hilbro Instruments (Pvt) Ltd | Pakistan | Maker | HILBRO INSTRUMENTS · SCALER, PERIODONTIC | — | — |
| Jiangxi IVISMILE Technology Co.,Ltd | China | Maker | Dental Teeth Cleaner | — | — |
| Medisporex Private Limited | Pakistan | Maker | MEDIS | — | — |
| Otto Leibinger GmbH | Germany | Maker | Dental Scaler · PERIODONTIC (MULTIPLE BRANDS) | — | — |
| Solventum US LLC | United States | Maker | Sickle-Style Cement Remover | — | — |
| Dentag SRL | Italy | Maker | DENTAG | — | — |
| Garish Apparels | Pakistan | Maker | Tamzon Instruments Inc. | — | — |
| Acme Enterprises | Pakistan | Maker | TBS Dental | — | — |
| W.H. Holden Inc. DBA H & H Company | United States | Maker | SCALERS | — | — |
| G.A. Surgical (Pvt.) Ltd. | Pakistan | Maker | DENTAL SCALERS | — | — |
| Acheron Instruments (Pvt.) Ltd. | Pakistan | Maker | Scalers | — | — |
| Goldman Products, Inc. | United States | Maker | Goldman · MicroDent | — | — |
| Harf Industries | Pakistan | Maker | SCALER, PERIODONTIC · 9 Molt Periosteal Elevator,Pitchard PPR3 Periosteal - Black Series | — | — |
| Silver Plus Corp. | Pakistan | Maker | SCALER, PERIODONTIC | — | — |
| Shanghai Medical Instruments (Group) Ltd. Corp. | China | Maker | PERIODONTIC SCALER | — | — |
| Surgiscape | Pakistan | Maker | SCALER, PERIODONTIC | — | — |
| Maryam Trading | Pakistan | Maker | MARYAM TRADING · Multi · SCALER, PERIODONTIC | — | — |
| Garana Industries (PVT) Ltd | Pakistan | Maker | PDL Dental Scalers | — | — |
| Towne Brothers (Pvt) Ltd | Pakistan | Maker | SCALER, PERIODONTIC | — | — |
| Biopsy Fine Cut Instruments | Pakistan | Maker | SCALER · SCALER, PERIODONTIC | — | — |
| Choose Surgical Instruments | Pakistan | Maker | SCALER, PERIODONTIC | — | — |
| Lohar Medical Company | Pakistan | Maker | EMN / SCALER, PERIODONTIC | — | — |
| Acme Commercial Ways Ltd. | Pakistan | Maker | Scalers | — | — |
| Nadir & Co. | Pakistan | Maker | Band Seater Stick · Ligature Director Double Ended · Tucker and Pusher | — | — |
| Y. Z. Corporation | Pakistan | Maker | YZ Dental Scalers | — | — |
| Daddy D Pro | Pakistan | Maker | Scalers, Detnal Scalers | — | — |
| Mount Blonck Trading | Pakistan | Maker | SCALER, PERIODONTIC | — | — |
| Crown Surgical Corp. | Pakistan | Maker | CROWN ECO | — | — |
| Surjex | Pakistan | Maker | Dental Scalers | — | — |
| Dimeda Instrumente GmbH | Germany | Maker | — | — | — |
| Pilotis Tech LLC | United States | Maker | Intrace USA | — | — |
| B. Braun Medical Industries Sdn. Bhd | Malaysia | Maker | Scaler | — | — |
| HILBRO International (Pvt) Ltd. | Pakistan | Maker | Hilbro Intl periodontic scaler | — | — |
| Mian Shahid Corp. | Pakistan | Maker | — | — | — |
| Zhongshan BestClean Technology Co.,Ltd. | China | Maker | Dental calculus remover · Plaque remover | — | — |
| M.M Dental Corp | Pakistan | Maker | Scalers | — | — |
| SGS Export Intl. | Pakistan | Maker | — | — | — |
| Spartech Instruments & Co. | Pakistan | Maker | SCALER, PERIODONTIC | — | — |
| Aimi Health Technology (Guangdong) Co., Ltd. | China | Maker | SCALER,PERIODONTIC-PERSMAX Ultrasonic Electric Dental Scaler, AOJ01, AOJ02, AOJ03, AOJ04, AOJ05 | — | — |
| Dr Frigz International Pvt Ltd | Pakistan | Maker | Dental Scalers | — | — |
| Med2B Ltd. | Germany | Maker | SCALER, PERIODONTIC | — | — |
| Melpex Beauty Instruments | Pakistan | Maker | SCALER, PERIODONTIC | — | — |
| Shandong Hengfeng Kerui Medical Equipment Co., Ltd | China | Maker | Dental scaler | — | — |
| Shenzhen Jie Bishi Technology Co., LTD | China | Maker | T11,T11 Pro,T11 Pro+,T12 Pro,T10,T99,T100,T200,T300,T9,T10 Pro,T12 Plus,T13,T13 Pro,T12,T20,T15,T15pr0,T18,T18pr0,T19 · T19pr0,T22,T22pro · Ultrasound tooth cleaning instrument | — | — |
| Armatech International | Pakistan | Maker | SCALER, PERIODONTIC | — | — |
| Central Surgical Co. Pvt. Ltd. | Pakistan | Maker | SCALER, PERIODONTIC, DENTAL SCALERS | — | — |
| Sabokay Industries | Pakistan | Maker | Scalar, Periodontic | — | — |
| Darleys Surgical Co. | Pakistan | Maker | SCALER, PERIODONTIC | — | — |
| Fabryka Narzedzi Medycznych CHIRMED Marcin Dyner Spolka Koma | Poland | Maker | Periodontic Scaler CHIRMED | — | — |
| Hazel Enterprises | Pakistan | Maker | SCALER, PERIODONTIC | — | — |
| Surgikare | Pakistan | Maker | SCALER, PERIODONTIC | — | — |
| T.A. Walthem & Company | Pakistan | Maker | SCALER, PERIODONTIC | — | — |
| Washington Surgical International | Pakistan | Maker | SCALER, PERIODONTIC | — | — |
| Zhongshan Xinhe Co.,Ltd | China | Maker | Scaler, Periodontic | — | — |
| Diligent Medical Ser | Pakistan | Maker | Scaler 5.25¿ | — | — |
| Hebu Medical GmbH | Germany | Maker | Scaler, Periodontic | — | — |
| Infirmary Medical Supplies | Pakistan | Maker | SCALER, PERIODONTIC | — | — |
| Madina Surgical Works | Pakistan | Maker | SCALER, PERIODONTIC | — | — |
| Shenzhen Yajiebao Technology Development Co., Ltd. | China | Maker | Electric dental scaler, Dental calculus remover, Electric teeth cleaner: M3, M3U, M5, M5U, M7, M7U, M8, M8U, M9, M9U, · M10, M11, T3, T3U, T5, T5U, T7, T8, T9, T10 | — | — |
| Alvi Expo | Pakistan | Maker | SCALER, PERIODONTIC | — | — |
| Hexamed Pvt Ltd | Pakistan | Maker | Dental Periodontic Scaler | — | — |
| Hospimed Mfg | Pakistan | Maker | Scaler Periodontic | — | — |
| Richbolt Enterprises | Pakistan | Maker | SCALERS · , S | — | — |
| Emerald Instruments | Pakistan | Maker | SCALER, PERIODONTIC | — | — |
| Ghousia Amanat Surgical | Pakistan | Maker | Scaler | — | — |
| Concise Enterprises | Pakistan | Maker | SCALER, PERIODONTIC | — | — |
| Mts Brothers Surgical Instruments | Pakistan | Maker | SCALER, PERIODONTIC | — | — |
| NR Surgical Company | Pakistan | Maker | SCALER, PERIODONTIC | — | — |
| Robinson Healthcare Limited | United Kingdom | Maker | Instrapac | — | — |
| Shenzhen Balinda Technology Co.,Ltd | China | Maker | Dental Scaler/Tartar Remover/Plaque Remover | — | — |
| Tim J. Prusaitis | United States | Maker | PRU-DENT | — | — |
| Tontarra Medizintechnik GmbH | Germany | Maker | Periodontic Scaler | — | — |
| Tess Oral Health | United States | Maker | Implant-Prophy+ | — | — |
| Power Dental USA | United States | Maker | SCALER, PERIODONTIC | — | — |
| Shenzhen Ainengke Electronics Co., Ltd. | China | Maker | Jacquette Scaler | — | — |
| Waqas Surgical Instruments | Pakistan | Maker | Plastic handles scalers set | — | — |
| Avilign Medical | Pakistan | Maker | scalar | — | — |
| Yangzhou Haiwang Toothbrush Factory | China | Maker | Scaler | — | — |
| Quality Concept (Pvt.) Ltd. | Pakistan | Maker | SCALER, PERIODONTIC | — | — |
| Shandong Richsource Biological Technology Co.,Ltd | China | Maker | Ultrasonic Electric Dental Scaler (KWJ-103) | — | — |
| Weihai Huihai Commodity Manufacture Co., Ltd. | China | Maker | LED Lighted Scaler with dentar Mirror · ScalerPick | — | — |
| Jay-Med | Pakistan | Maker | SCALER; SCALER, PERIODONTIC | — | — |
| Magenta Technology International Limited | China | Maker | Electric Teeth Cleaner (YJK031,YJK015A, L156, 161X, 701), Dental Denture Cleaner | — | — |
| Skill To Tech International | Pakistan | Maker | SCALER, PERIODONTIC | — | — |
| Stomed Corp. | Pakistan | Maker | SCALER, PERIODONTIC | — | — |
| Cixi Qimei Combination Tool Packing Factory | China | Maker | SCALER, PERIODONTIC | — | — |
| Shurcon Manufacturing Company | China | Maker | ACCS SCALER, PERIODONTIC | — | — |
| Verdent Ltd. | Poland | Maker | Verdent dental scalers | — | — |
| Dongguan Yipincheng Technology Co., Ltd. | China | Maker | Dental Plaque Remover T11 T11 Pro T11 Pro+ T12 Pro T10 T99 T100 T200 T300 T9 T10 Pro T12 Plus T13 T13 Pro T12 T20 T15 · T15pro T18 T18pro T19 T19pro T22 T22pro | — | — |
| Hangzhou Rollmed Co.,Ltd. | China | Maker | scale | — | — |
| J&J Instruments | United States | Maker | — | — | — |
| LA MAISON DENTAIRE / Medirel SA | Switzerland | Maker | Flexible Scaler | — | — |
| Ningbo Ranor Medical Science & Technology Co., Ltd. | China | Maker | Dental Scaler; RN1Y · Dental Scaler; RN2Y · Dental Scaler; RN3Y · Dental Scaler; RN4Y · +2 | — | — |
| Perfect Group Corp. Ltd. | China | Maker | — | — | — |
| Yangjiang Kaimi Import Export Co.,Ltd | China | Maker | SCALER, PERIODONTIC | — | — |
| Mecmed Medical | Pakistan | Maker | Scaler Dental | — | — |
| S.G. Manufacturers | Pakistan | Maker | SCALER, PERIODONTIC | — | — |
| A Fone Surgico | Pakistan | Maker | SCALER, PERIODONTIC | — | — |
| Daud Jee Mfg Co | Pakistan | Maker | Dental Scaler | — | — |
| Hive International Pvt Ltd. | Pakistan | Maker | Dental Scalers. | — | — |
| Kohler Medizintechnik GmbH | Germany | Maker | 9529 | — | — |
| Shenzhen Lunata Technology Co., Ltd | China | Maker | SCALER, PERIODONTIC | — | — |
| Surgicon Pvt Ltd | Pakistan | Maker | SCALER, PERIODONTIC | — | — |
| Varco International | Pakistan | Maker | EMN / SCALER, PERIODONTIC | — | — |
| Dongguan Jifan Electric Appliance Co., LTD | China | Maker | Dental Calculus Remover, J09, J10, J12 | — | — |
| Dongguan Yingtong Precision Components Co. Ltd | China | Maker | oral irrigator | — | — |
| Shenzhen Rainbow Technology Co.,Ltd | China | Maker | Ultrasonic Teeth cleaner,ultrasonic dental cleaner,RB-016, RB-016B,RB-016C,RB-016D, RB-016F,RB-016G | — | — |
| Aura Medical LLC | United States | Maker | Illumine Scaler | — | — |
| Gaboss International Limited | China | Maker | tooth cleaner | — | — |
| Phoenix Instruments, Inc. | United States | Maker | — | — | — |
| Platts and Nisbett Ltd. | United Kingdom | Maker | PLATTS & NISBETT | — | — |
| Pro-Dex Inc | United States | Maker | Dynatip P/N 3293 Tip, Cover / Protector | — | — |
| USTOMED INSTRUMENTE GmbH & Co. KG | Germany | Maker | — | — | — |
| Xinhua Surgical Instrument Co.,Ltd. | China | Maker | — | — | — |
| Coda Resources Ltd., Heze China | China | Maker | — | — | — |
| Devemed GmbH | Germany | Maker | — | — | — |
| GLW, Inc. | United States | Maker | — | — | — |
| Gulmag International | Pakistan | Maker | — | — | — |
| Helmut Zepf Medizintechnik GmbH | Germany | Maker | — | — | — |
| Nextcon International | Pakistan | Maker | — | — | — |
| Sinntech Medical (Private) Limited | Pakistan | Maker | — | — | — |
| Tekno-Medical Optik-Chirurgie GmbH | Germany | Maker | — | — | — |
| Wise Instruments | Pakistan | Maker | — | — | — |
| B.t.i. Biotechnology | Spain | Foreign exporter | — | 14 | 2024 |
| Ortho Organizers, Inc. | United States | Manufacturer | ClassOne Classic Cement Spatula and Scaler · ClassOne Classic Single Ended Scaler | 8 | 2025 |
| Pulpdent Corporation | United States | Manufacturer | Flexible Scaler | 107 | 2021 |
| Tpc Advanced Technology, Inc. | United States | Repacker / relabeler | TPC Advance 750 Piezo Perio Scaler | 3 | 2007 |
| Integra LifeSciences Corporation | United States | Contract manufacturer | Integra · Miltex | 2 | 2014 |
| Aesculap, Inc. | United States | Lister | Aesculap | 2 | 2006 |
| Dentimed Sao Joao LLC | United States | Repacker / relabeler | ANGELUS | — | — |
| TitanLinks Logistics LLC | United States | Repacker / relabeler | Ultrasonic Inserts | — | — |
| Jmu Dental, Inc. | United States | Repacker / relabeler | JMU Ultrasonic Scaler Tip | — | — |
| Patterson Companies, Inc. | United States | Foreign exporter | Patterson Scalers | — | — |
| Soher Med Limited | Hong Kong SAR China | Foreign exporter | — | — | — |
| STERIS Corporation | United States | Contract sterilizer | — | — | — |
| Premium Plus Dental | United States | Lister | — | — | — |
| GoldenDent | United States | Repacker / relabeler | GoldenDent | — | — |
| Yizur Ltd | Hong Kong SAR China | Foreign exporter | Scaler | — | — |
| TBS Dental | United States | Repacker / relabeler | TBS INOX USA | — | — |
| Wise Linkers LLC | United States | Repacker / relabeler | Artman Instruments | — | — |
| Sklar Corporation | United States | Repacker / relabeler | Scaler | — | — |
| Maxill Inc. | United States | Foreign exporter | Maxill | — | — |
| YCH Distripark Sdn Bhd | Malaysia | Foreign exporter | Scaler | — | — |
| E A Beck & Company | United States | Repacker / relabeler | SCALER, PERIODONTIC | — | — |
| Sontec Instruments Inc | United States | Repacker / relabeler | MULTIPLE | — | — |
| HI Medical Co., Ltd. | South Korea | Foreign exporter | Dentsply | — | — |
| Peak Implements Inc | United States | Repacker / relabeler | SCALER, PERIODONTIC | — | — |
| Sanicure BV | Netherlands | Foreign exporter | — | — | — |
| Zapalign LLC | United States | Repacker / relabeler | — | — | — |
| O&S Dental Inc | United States | Manufacturer for export | Orthodontic Scaler | — | — |
| SurgiPros LLC | United States | Repacker / relabeler | SURGIPROS | — | — |
| simex Medizintechnik GmbH | Germany | Repacker / relabeler | Scaler, Periodontic | — | — |
| Magnum Medical | United States | Repacker / relabeler | Scaler Dental | — | — |
| Novo Surgical Inc. | United States | Repacker / relabeler | — | — | — |
| US Health Express Corp | United States | Lister | Metiko M5 Dental Calculus Remover Teeth Cleaning Kit · Metiko M5 Plaque and Tartar Remover for Teeth · Metiko M5 Ultrasonic Dental cleaner · Metiko M5 Ultrasonic Teeth cleaner | — | — |
| Kash Sales Inc. | Canada | Foreign exporter | — | — | — |
| Olulo LLC | United States | Repacker / relabeler | — | — | — |
| Rechar Inc. | United States | Repacker / relabeler | tooth cleaner | — | — |
| Coda Resources Ltd | United States | Lister | — | — | — |
| Mainline Medical Dental Supply | Canada | Foreign exporter | — | — | — |
| Oketz Logistics LLC | United States | Repacker / relabeler | — | — | — |
| Vehu Medical Instrumente GmbH | Germany | Repacker / relabeler | — | — | — |
| Wise Instruments Inc | United States | Repacker / relabeler | — | — | — |
| Worldwide Supplies Limited | Hong Kong SAR China | Foreign exporter | — | — | — |
| Zircon Plus Limited | Israel | Foreign exporter | — | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 29 Mar 2007 | K070127 | PLAQUE SCRAPER-A INTERPROXIMAL (BETWEEN TEETH) PLAQUE REMOVER, MODEL Z01, Z02 | Kevin Vu, Dds |
| 26 Jan 1994 | K931330 | DENTAL INSTRUMENTS SCALER | Minnesota Prophy Power, Inc. |
| 2 Jul 1985 | K851721 | 1200/1 TO 1240/15 VARIOUS TYPES OF DENTAL SCALERS | Artiberia |
| 6 Jul 1982 | K821786 | BEACH SCALERS | Pacific Dental Corp. |
| 30 Jun 1978 | K781035 | PERIODONTAL INSTRUMENT #21 GOLDMAN-FOX | Premier Dental Products Company |
Official records: FDA product classification for EMN · 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