Miscellaneous devices · 21 CFR 872 Subpart G
Abrasive Disk
FDA device type “Disk, Abrasive”.
- Companies listing it
- 7846 makers
- Brands and models
- 559
- 510(k) clearances
- 40 in five years
- FDA name
- Disk, Abrasive
510(k) clearances per year, 1976–2026
Companies that list EHJ
78 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Dentsply Sirona, Inc. | United States | Maker | — | 148 | 2026 |
| Prismatik Dentalcraft, Inc. | United States | Maker | BruxZir Adjustment & Polishing Kit · BruxZir Adjustment and Polishing Kit · BruxZir Blue Polishing Disc (3-pack) Refill · BruxZir Blue Polishing Disc, 3/Pk · +10 | 56 | 2026 |
| Voco GmbH | Germany | Maker | Dimanto | 117 | 2026 |
| Shofu Inc | Japan | Maker | SUPER-SNAP | 96 | 2025 |
| Sybron Dental Specialties | United States | Maker | Composite Surface Treatment · OptiDisc | 203 | 2026 |
| Ivoclar Vivadent, AG | United States | Maker | OptraGloss · Politip | 94 | 2026 |
| Premier Dental Products Company | United States | Maker | Premier Poli-Pro polishing System | 28 | 2026 |
| Centrix, Inc. | United States | Maker | ProxiDiscs - Smooth | 44 | 2025 |
| Vericom Co., Ltd. | South Korea | Maker | EAZI-BRUSH | 20 | 2026 |
| Coltene/Whaledent AG | Switzerland | Maker | Diatech, SwissTEC Disks · Disposable KENDA Big Job · Disposable KENDA C.G.I. · Disposable KENDA Composite Microfill · +22 | 45 | 2022 |
| Ortho Organizers, Inc. | United States | Maker | — | 8 | 2025 |
| Garrison Dental Solutions LLC | United States | Maker | Rally | 3 | 2024 |
| Micerium S.P.A. | Italy | Maker | ENA SHINY | 6 | 2011 |
| Integra LifeSciences Corporation | United States | Maker | Integra · Miltex | 2 | 2014 |
| Microcopy, Div. Neo-Flo, Inc. | United States | Maker | — | 2 | 1989 |
| Gebr. Brasseler GmbH & Co. KG | Germany | Maker | KOMET ABRASIVE DISK | 1 | 2007 |
| Abrasive Technology, Inc. | United States | Maker | — | 1 | 1990 |
| E. C. Moore Company, Inc. | United States | Maker | E.C. Moore; Cosmedenr | 1 | 1979 |
| TOR VM Ltd. | Russia | Maker | Cat.#1.110 Mandrel for Stem Polishing Discs HP type · Cat.#1.111 Mandrel for Stem Polishing Discs RA type · Cat.#1.113 Mandrel for Stem Polishing Discs HP type · Cat.#1.115 Mandrel for Stem Polishing Discs RA type · +412 | — | — |
| Dentaurum GmbH & Co. KG | Germany | Maker | Corundum disc · Diasint Diamond disc · Disk Abrasive | — | — |
| Prodont-Holliger | France | Maker | Article : PRODONT CUT OFF WHEEL AP3707011 · Article : PRODONT CUT OFF WHEEL AP3710011 · Article : PRODONT CUT OFF WHEEL AP3717011 · Article : PRODONT SPEEDY CUT OFF AP2206011 · +6 | — | — |
| TDV Dental Ltda | Brazil | Maker | Finishing and Polishing Discs · Finishing and Polishing Discs Mandrel · PRAXIS · Praxis Mandrel · +4 | — | — |
| 3R Industria e Comercio Ltda | Brazil | Maker | Disk, Rubber Cup and Cone for Dentistry - Polishing and Finishing | — | — |
| Huanghua Promisee Dental Co., Ltd | China | Maker | Polishing Discs | — | — |
| Falcon Surgical Co. (Pvt.) Ltd. | Pakistan | Maker | DISK, ABRASIVE | — | — |
| Shanghai Dochem Industries Co., Ltd. | China | Maker | Cosmetic Discs | — | — |
| DFS-Diamon GmbH | Germany | Maker | — | — | — |
| Solventum US LLC | United States | Maker | — | — | — |
| Teleflex | United States | Maker | PILLING · PINEHOLE | — | — |
| Onvet Medical Canada Inc. | Canada | Maker | SurePoli Polishing Disc System, SureFita IPR system | — | — |
| Everbrands, Inc. | United States | Maker | Dental Disk; Dental Rotary Instruments; Diamond Dental Rotary Instruments · ES-SMDISK-PRO-001 · ES-SMDISK-PRO-002 · ES-SMDISK-PRO-003 · +5 | — | — |
| MDT Micro Diamond Technologies Ltd | Israel | Maker | Dental Disc · Dental Rotary Instruments · Diamond Dental Rotary Instruments | — | — |
| Jordco Inc | United States | Maker | Pure Buff: Acrylic Polishing Kit · Pure Buff: Acrylic Polishing Wheels (refill pack) | — | — |
| BUSCH & CO. GmbH & Co. KG | Germany | Maker | ABRASIVE DEVICE AND ACCESSORIES · UNMOUNTED WHEELS | — | — |
| PHS Do Brasil LTDA | Brazil | Maker | POTENZA FINEX CUT · POTENZA FINEX DISC · POTENZA FINEX MANDREL | — | — |
| Shanghai Toboom Dental Techology CO., LTD. | China | Maker | DISK, ABRASIVE | — | — |
| Diaswiss, S. A. | Switzerland | Maker | DISK, ABRASIVE | — | — |
| Dedeco International, Inc. | United States | Maker | Disk Abrasive | — | — |
| Jota AG | Switzerland | Maker | JOTA | — | — |
| Zentro Enterprise Pvt. Ltd. | India | Maker | DISK, ABRASIVE | — | — |
| Hopf Ringleb & Co GmbH & Cie | Germany | Maker | HORICO | — | — |
| Josef Ganter Feinmechanik GmbH | Germany | Maker | Disk, Abrasive · MANDRELS FOR VARIOUS TYPES OF | — | — |
| Reco-Dent International Co., Ltd. | Taiwan | Maker | Abrasive Disk | — | — |
| Fischer Surgical Inc. | United States | Maker | DISK, ABRASIVE | — | — |
| Dr Hopf GmbH and Co KG | Germany | Maker | SUNSHINE DIAMONDS | — | — |
| Eve Ernst Vetter GmbH | Germany | Maker | — | — | — |
| Ultradent Products, Inc. | United States | Contract manufacturer | JIFFY CUPS · JIFFY DISKS · Jiffy HiShine Cups · Jiffy HiShine Disks · +3 | 95 | 2026 |
| Kulzer, LLC | United States | Contract manufacturer | Venus Supra | 37 | 2026 |
| Young Innovations Inc | United States | Contract manufacturer | The Ortho Store & Johnson Promident Diamond Discs & Strips | 23 | 2025 |
| Parkell, Inc | United States | Contract manufacturer | — | 58 | 2025 |
| Cosmedent, Inc. | United States | Repacker / relabeler | FlexiDisc · FlexiWheel | 27 | 2024 |
| Den-Mat Holdings, LLC | United States | Manufacturer | A.S.A.P.® All Surface Access Polishers · A.S.A.P.® Dailies · A.S.A.P.® Diamond Polishing Brushes · A.S.A.P.® Indrect+ All Surface Access Polishers Extraoral · +2 | 8 | 2026 |
| Imicryl Dis Malzemeleri Sanayi VE Ticaret AS | Türkiye | Manufacturer | ROLENE | 5 | 2022 |
| ITENA Clinical | France | Private-label distributor | DISK, ABRASIVE | 8 | 2017 |
| Hager Worldwide, Inc. | United States | Manufacturer | — | 2 | 2005 |
| Ziacom Medical, S.L. | Spain | Foreign exporter | JOTA | 1 | 2019 |
| One Dashcorp | United States | Repacker / relabeler | Valdent USA RA Mandrel, Contra-Angle | — | — |
| Jersey Dental Supplies | United States | Repacker / relabeler | — | — | — |
| Dentimed Sao Joao LLC | United States | Repacker / relabeler | TORINO | — | — |
| TitanLinks Logistics LLC | United States | Repacker / relabeler | — | — | — |
| Patterson Companies, Inc. | United States | Foreign exporter | Patterson Abrasive Disk | — | — |
| Soher Med Limited | Hong Kong SAR China | Foreign exporter | — | — | — |
| Aspen Surgical Products | United States | Contract manufacturer | Symmetry Surgical | — | — |
| Samtrade Supplies Inc. | Canada | Foreign exporter | Soflex / Enhance polishing | — | — |
| Summit Orthodontic Services, Inc. | United States | Repacker / relabeler | ECONO CUTTER · Scotchbrite abrasive wheels | — | — |
| International Orthodontics Services. PC | United States | Repacker / relabeler | Diamond Disc 3/4 and 7/8 | — | — |
| Premium Plus Dental | United States | Lister | DISK ABRASIVE | — | — |
| Yizur Ltd | Hong Kong SAR China | Foreign exporter | Finishing Material | — | — |
| Ortho Solutions LC | United States | Contract manufacturer | — | — | — |
| Zapalign LLC | United States | Repacker / relabeler | — | — | — |
| Peter Brasseler Holdings, LLC | United States | Contract manufacturer | — | — | — |
| Opa Dental, LLC | United States | Repacker / relabeler | — | — | — |
| Kash Sales Inc. | Canada | Foreign exporter | — | — | — |
| Dylan Lucas International Inc | Canada | Foreign exporter | — | — | — |
| Mainline Medical Dental Supply | Canada | Foreign exporter | — | — | — |
| MHM Grupo Diamante, S.A. de C.V. | Mexico | Foreign exporter | — | — | — |
| Oketz Logistics LLC | United States | Repacker / relabeler | — | — | — |
| Tas Medical Supply | United States | Foreign exporter | — | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 19 Nov 1991 | K911111 | MICROMILLS, PATRIOTS, ALPHA GOLD DIAMONDS | Vermont Diamond Instruments |
| 17 Aug 1987 | K873002 | MIN-IDENTOFLEX | Centrix, Inc. |
| 1 May 1979 | K790640 | HOWMEDICA BRASS CENTER DISC | E. C. Moore Company, Inc. |
| 12 Sep 1977 | K771658 | IDENTOFLEX | Cavitron Corp. |
Official records: FDA product classification for EHJ · 21 CFR 872.6010.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026