Miscellaneous devices · 21 CFR 872 Subpart G
Abrasive Point
FDA device type “Point, Abrasive”.
- Companies listing it
- 7941 makers
- Brands and models
- 240
- 510(k) clearances
- 40 in five years
- FDA name
- Point, Abrasive
510(k) clearances per year, 1976–2026
Companies that list EHL
79 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Shofu Inc | Japan | Maker | ACRYLIC KIT HP · ACRYLIC POLISHING KIT · ACRYLIC POLISHING KIT HP · ACRYPOINT · +44 | 96 | 2025 |
| Sybron Dental Specialties | United States | Maker | Acrylic Adjustment Logic Set · AXIS Laminate Veneer Set · Bite Adjustment Logic Set · Cera-Glaze Ultimate Porcelain Logic Set · +69 | 203 | 2026 |
| Hager& Meisinger GmbH | Germany | Maker | MEISINGER Abrasives | 14 | 2025 |
| Coltene/Whaledent AG | Switzerland | Maker | Diatech, SwissTEC, SwissBurs · Disposable KENDA Big Job · Disposable KENDA C.G.I. · Disposable KENDA Composite Microfill · +22 | 45 | 2022 |
| Garrison Dental Solutions LLC | United States | Maker | eZr · Rally | 3 | 2024 |
| Reliance Orthodontic Products, Inc. | United States | Maker | Renew Finishing System Burs · Renew System Points | 32 | 2021 |
| Micerium S.P.A. | Italy | Maker | ENA SHINY | 6 | 2011 |
| Microcopy, Div. Neo-Flo, Inc. | United States | Maker | NeoShine | 2 | 1989 |
| Dental Morelli | Brazil | Maker | — | 2 | 2014 |
| Gebr. Brasseler GmbH & Co. KG | Germany | Maker | KOMET ABRASIVE POINT | 1 | 2007 |
| Abrasive Technology, Inc. | United States | Maker | PRODIA · STAINBUSTER | 1 | 1990 |
| E. C. Moore Company, Inc. | United States | Maker | E.C. Moore | 1 | 1979 |
| TDV Dental Ltda | Brazil | Maker | ACRYL POLISH · DIAMOND POLISH CERAM-CLINIC · DIAMOND POLISH CERAM-LAB · DIAMOND POLISH COMPO-CLINIC · +12 | — | — |
| 3R Industria e Comercio Ltda | Brazil | Maker | Silicone Tips for Finishing and Polishing | — | — |
| Huanghua Promisee Dental Co., Ltd | China | Maker | Composite Polisher | — | — |
| Polydentia S.A. | Switzerland | Maker | Abrasive Polishing Strip · Tria-Shine | — | — |
| Dentatus AB | Sweden | Maker | EVA Tips · LTA Lamineer Tips · Per-io-Tor Tips | — | — |
| Tangshan Zhengtong Exhibition Co., Ltd. | China | Maker | — | — | — |
| DFS-Diamon GmbH | Germany | Maker | — | — | — |
| Anqing Clean Dental Instrument Technology Co Ltd | China | Maker | POINT, ABRASIVE | — | — |
| Henan Baistra Medical Devices Limited | China | Maker | POINT, ABRASIVE | — | — |
| Henan Lusterdent Medical Instrument Co.,Ltd | China | Maker | Abrasive Diamond Strips | — | — |
| MDT Micro Diamond Technologies Ltd | Israel | Maker | Daisy · Dental Rotary Instruments · Dental Rotary Polishers · MONOSTERYL · +1 | — | — |
| Gavin Biotechnology Co.,ltd | China | Maker | Utrasonic Tips ( for EMS/SATALEC/WOODPECKER/KAVO/SIRONA) | — | — |
| BUSCH & CO. GmbH & Co. KG | Germany | Maker | ABRASIVE DEVICE AND ACESSORIES · MOUNTED POINTS | — | — |
| Edenta Etablissement | Liechtenstein | Maker | CERAGLAZE · DIAGLOSS AND PDQ · NTI | — | — |
| Bio-Art Equipamentos Odontologicos Ltda | Brazil | Maker | Microblaster Standard | — | — |
| Peter Brasseler Holdings, LLC | United States | Maker | — | — | — |
| Shanghai Toboom Dental Techology CO., LTD. | China | Maker | POINT, ABRASIVE | — | — |
| Chung Song Industrial Co. | South Korea | Maker | ABRASIVE STONE POINT | — | — |
| Diaswiss, S. A. | Switzerland | Maker | POINT, ABRASIVE | — | — |
| Dedeco International, Inc. | United States | Maker | Point Abrasive | — | — |
| Jota AG | Switzerland | Maker | JOTA | — | — |
| Chi Feng Co.,ltd | Taiwan | Maker | Sand Trap | — | — |
| Hopf Ringleb & Co GmbH & Cie | Germany | Maker | HORICO | — | — |
| Ningbo Xinwell Medical Technology Co., Ltd. | China | Maker | All Ceramic Polishers · FlexiPoints · MASS SPECTROMETRY MONITORING LINE CONONECTORS | — | — |
| Dr Hopf GmbH and Co KG | Germany | Maker | — | — | — |
| Eve Ernst Vetter GmbH | Germany | Maker | — | — | — |
| SUN Oberflaechentechnik GmbH | Germany | Maker | Polisher for dental use | — | — |
| BBC Cellpack Technology AG | Switzerland | Maker | — | — | — |
| Dentex Dental Industrial Corp | Taiwan | Maker | — | — | — |
| Voco GmbH | Germany | Foreign exporter | SiC Grinding Bur · Trimming Disk | 117 | 2026 |
| Zest Anchors, LLC | United States | Manufacturer | — | 26 | 2026 |
| Ultradent Products, Inc. | United States | Contract manufacturer | Jiffy Natural Composite Polishing Kit · Jiffy Natural Universal Intra-Oral Polishing Kit · Jiffy Universal Adjusting & Polishing Kits | 95 | 2026 |
| Young Innovations Inc | United States | Contract manufacturer | Johnson Promident | 23 | 2025 |
| Cosmedent, Inc. | United States | Repacker / relabeler | All Ceramic Polishers · FlexiPoints · MASS SPECTROMETRY MONITORING LINE CONONECTORS | 27 | 2024 |
| Den-Mat Holdings, LLC | United States | Manufacturer | Groovy Diamond® Polishing Brushes | 8 | 2026 |
| Vita Zahnfabrik H. Rauter GmbH & Co. Kg. | Germany | Manufacturer | VITA ENAMIC Polishing Set VITA SUPRINITY® Polishers | 8 | 2026 |
| Amann Girrbach AG | Austria | Foreign exporter | — | 3 | 2026 |
| Buffalo Dental Mfg. Co., Inc. | United States | Manufacturer | ABRASIVES | 11 | 1996 |
| ITENA Clinical | France | Private-label distributor | POINT, ABRASIVE | 8 | 2017 |
| Dentatus USA Ltd. | United States | Repacker / relabeler | LTA/EVA tips | 4 | 2004 |
| DB Orthodontics Limited | United Kingdom | Foreign exporter | Airo Interdental Strips | 2 | 2010 |
| SS White Burs LLC | United States | Manufacturer | Jazz Polisher | 1 | 2008 |
| Sotera Health LLC | United States | Contract manufacturer | — | — | — |
| Jersey Dental Supplies | United States | Repacker / relabeler | ACRYPOINT; BROWNIE; BURBUTLER ALL CERAMIC ABRASIVE KIT; BURBUTLER CADMASTER KIT; CERAMASTER; CERAMISTE; CERAMISTE SOFT; | — | — |
| Dentimed Sao Joao LLC | United States | Repacker / relabeler | TORINO | — | — |
| TitanLinks Logistics LLC | United States | Repacker / relabeler | Finishing & Polishing | — | — |
| Jmu Dental, Inc. | United States | Repacker / relabeler | Micro blaster Standard (Midwest) | — | — |
| Soher Med Limited | Hong Kong SAR China | Foreign exporter | abrasive | — | — |
| STERIS Corporation | United States | Contract sterilizer | WhiteBurr3283 (WP, CH1) - Jazz Polisher | — | — |
| Summit Orthodontic Services, Inc. | United States | Repacker / relabeler | Abrasive Points · Polishing Points | — | — |
| Premium Plus Dental | United States | Lister | House Brand Point Abrasive · MEISINGER Abrasives | — | — |
| Yizur Ltd | Hong Kong SAR China | Foreign exporter | Finishing & Polishing | — | — |
| First Dental Supplies LLC | United States | Repacker / relabeler | POINT, ABRASIVE | — | — |
| Meta Dental Corp. | United States | Repacker / relabeler | ABRASIVE STONE POINT | — | — |
| Sanicure BV | Netherlands | Foreign exporter | — | — | — |
| Zapalign LLC | United States | Repacker / relabeler | — | — | — |
| Prais Reliable Dental Supplies S.A | Seychelles | Foreign exporter | — | — | — |
| Maverick Dental, LLC | United States | Repacker / relabeler | EraseZir · Re-Glaze | — | — |
| ACURATA GMBH & CO. KGaA | Germany | Manufacturer | Acurata | — | — |
| Opa Dental, LLC | United States | Repacker / relabeler | — | — | — |
| Kash Sales Inc. | Canada | Foreign exporter | — | — | — |
| Strauss & Co. | Israel | Manufacturer | Strauss & Co. Polishers | — | — |
| 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 | — | — | — |
| Pharmco Medical B.V. | Netherlands | Foreign exporter | — | — | — |
| Worldwide Supplies Limited | Hong Kong SAR China | Foreign exporter | — | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 23 Jan 1980 | K792250 | CUTTER POINTS | Cutter Laboratories, Inc. |
| 22 Jun 1978 | K780811 | DENTAL ABRASIVE DEVICE | Cavitron Corp. |
| 14 Mar 1978 | K780377 | PINIDENTOFLEX DENTAL POLISHER | Cavitron Corp. |
| 14 Mar 1978 | K780376 | MINIDENTOFLEX NEW POLISHING SYSTEM | Cavitron Corp. |
Official records: FDA product classification for EHL · 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