Miscellaneous devices · 21 CFR 872 Subpart G
Polishing Agent Strip
FDA device type “Strip, Polishing Agent”.
- Companies listing it
- 8252 makers
- Brands and models
- 191
- 510(k) clearances
- 20 in five years
- FDA name
- Strip, Polishing Agent
510(k) clearances per year, 1976–2026
Companies that list EHM
82 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Dentsply Sirona, Inc. | United States | Maker | Flex-View Interproximal Strips · Interproximal Serrated Strips | 148 | 2026 |
| Shofu Inc | Japan | Maker | SUPER-SNAP IPR · SUPER-SNAP POLYSTRIPS | 96 | 2025 |
| GC America Inc. | United States | Maker | EPITEX · EPITEX FINISHING · GC Metal Strips · POLISHING STRIPS · +1 | 137 | 2026 |
| Premier Dental Products Company | United States | Maker | Denmat Ceri-Sander | 28 | 2026 |
| Hager& Meisinger GmbH | Germany | Maker | MEISINGER Prophy Strips | 14 | 2025 |
| Ortho Organizers, Inc. | United States | Maker | Galaxy | 8 | 2025 |
| Tp Orthodontics, Inc. | United States | Maker | MESIO-DISTAL REDUCER | 5 | 2022 |
| Shenzhen Rogin Medical Co., Ltd. | China | Maker | Polishing Disc/Polishing Strips/Polishing Cup/Polishing Brushes | 1 | 2025 |
| Micerium S.P.A. | Italy | Maker | ENA SHINY | 6 | 2011 |
| Premium Plus International Limited | Hong Kong SAR China | Maker | Finishing Strips single/double size coated | 3 | 2017 |
| Integra LifeSciences Corporation | United States | Maker | EvenWet · Lightning · Miltex · Spectra A · +1 | 2 | 2014 |
| Microcopy, Div. Neo-Flo, Inc. | United States | Maker | NeoDiamond IPR Strips | 2 | 1989 |
| World Bio Tech Co Ltd | South Korea | Maker | AUTOMATIC STRIP, EASY STRIP, OTO STRIP | 2 | 2016 |
| Dfl Industria E Comercio SA | Brazil | Maker | Steel Strips | 2 | 2013 |
| Dental Morelli | Brazil | Maker | — | 2 | 2014 |
| Directa AB | Sweden | Maker | ContacEZ Diamond Dental Strip · ContacEZ kits | 1 | 2015 |
| COLTENE Holding AG | Switzerland | Maker | Alpen Steel separating strips | 1 | 2003 |
| Gebr. Brasseler GmbH & Co. KG | Germany | Maker | KOMET POLISHING STRIP | 1 | 2007 |
| Abrasive Technology, Inc. | United States | Maker | COMPO-STRIP · Two Striper Diamond Finishing Strips | 1 | 1990 |
| Sawbros Industries Pvt., Ltd. | India | Maker | IPR Files · Separating · Separating Strips | 1 | 2017 |
| E. C. Moore Company, Inc. | United States | Maker | E.C. Moore; Cosmedent | 1 | 1979 |
| Osung Mnd Co Ltd | South Korea | Maker | SRTD15 · SRTD15H · SRTD25 · SRTD25H · +21 | — | — |
| TOR VM Ltd. | Russia | Maker | Cat.#1.150 Metal Diamond Strips (Coarse) · Cat.#1.150(3) Metal Diamond Strips (Coarse) · Cat.#1.151 Metal Diamond Strips (Medium) · Cat.#1.151(3) Metal Diamond Strips (Medium) · +29 | — | — |
| Dentaurum GmbH & Co. KG | Germany | Maker | Ultrasonic cleaning solution | — | — |
| Shenzhen Denco Medical Co Ltd | China | Maker | Polishing Disc/Polishing Strips/Polishing Cup/Polishing | — | — |
| TDV Dental Ltda | Brazil | Maker | ABRASIVE STEEL STRIP · APPROXIMAL FINISHING SANDPAPER · DIAMOND STRIP · SeptoDiamond Strips · +3 | — | — |
| 3R Industria e Comercio Ltda | Brazil | Maker | MIR 1 · MIR 2 · MIR Prime 1 · Strip, Polishing Agent - MICRODONT - STRIP POLISHING AGENT | — | — |
| Huanghua Promisee Dental Co., Ltd | China | Maker | Prophy strip | — | — |
| Tangshan Zhengtong Exhibition Co., Ltd. | China | Maker | — | — | — |
| OSSTEM ORTHODONTICS Inc. | South Korea | Maker | 650-08 Perforated Strip · 650-09 Reducer Strip(Thick) · 650-10 Reducer Strip(Thin) · 650-12 Reducer Strip(One-side) | — | — |
| Intensiv SA | Switzerland | Maker | Intensiv ApproxOpener · Intensiv Bevelshape · Intensiv Metal Diamond Strips · Intensiv Ortho-Strips · +14 | — | — |
| Produits Dentaires SA | Switzerland | Maker | Diamond Abrasive Strips · Odus Universal Strips · Steel Abrasive Strips · Transparent Strips | — | — |
| Henan Baistra Medical Devices Limited | China | Maker | Polishing Strip | — | — |
| MDT Micro Diamond Technologies Ltd | Israel | Maker | MDT DIAMOND DENTAL STRIPS | — | — |
| Onuge Personal Care(Guangdong)Manufacturer Group Co., LTD. | China | Maker | BocaBella Natural Teeth Whitening Strips · BocaBella Teeth Whitening U-wraps · Charcoal Teeth Whitening Strips · CVSHealth Brilliant White Whitening Strips(Coconut flavor) · +6 | — | — |
| Hangzhou Wise Medical Device Co.,Ltd | China | Maker | Polishing Strip | — | — |
| Maquira Industria de Produtos Odontologicos | Brazil | Maker | AIRON POLYESTER ABRASIVE STRIPS · AIRON STEEL ABRASIVE STRIP | — | — |
| LLRN Personal Care (Shenzhen) Co.,ltd | China | Maker | Teeth whitening kit, Teeth Whitening Strips | — | — |
| Ashtel Studios, Inc. | United States | Maker | Teeth whitening strips | — | — |
| Changsha Easyinsmile Intelligence Technology Co.,Ltd. | China | Maker | Dental Strip | — | — |
| Guangxi Ehall Medical Technology Co.,Ltd | China | Maker | Prophy cup, Nylon Prophy Brush, Prophy Angle, Proply Motor X1 | — | — |
| Garnet Dentech | South Korea | Maker | Dental Orthodontic Strip | — | — |
| Shenzhen Mold and Manufacturing Co Ltd | China | Maker | Beaming White | — | — |
| Weihai Jieshi Commodity Manufacture Co., Ltd. | China | Maker | Dental whitening strip | — | — |
| Indusbello Ind. e Com. de Prod. Med. e Odont. Ltda. | Brazil | Maker | INDUSBELLO | — | — |
| Prima Dental Group | United Kingdom | Maker | Polisher, Dental · Prima Dental Illume | — | — |
| Hangzhou Rollmed Co.,Ltd. | China | Maker | STRIP CAP | — | — |
| Hopf Ringleb & Co GmbH & Cie | Germany | Maker | HORICO | — | — |
| Dome Inc. | United States | Maker | Dome abrasive | — | — |
| Dr Hopf GmbH and Co KG | Germany | Maker | — | — | — |
| Eve Ernst Vetter GmbH | Germany | Maker | — | — | — |
| Samson Innovation Corp. Ltd. | Hong Kong SAR China | Maker | — | — | — |
| Sybron Dental Specialties | United States | Contract manufacturer | Perforated Diamond Strips | 203 | 2026 |
| Ultradent Products, Inc. | United States | Contract manufacturer | JIffy Diamond Strips · JIFFY PROXIMAL SAW-FINISH | 95 | 2026 |
| Centrix, Inc. | United States | Contract manufacturer | GripStrip Inter-Proximal Polisher | 44 | 2025 |
| Cosmedent, Inc. | United States | Repacker / relabeler | FlexiStrip | 27 | 2024 |
| Coltene/Whaledent AG | Switzerland | Contract manufacturer | Alpen Polishers | 45 | 2022 |
| SS White Burs LLC | United States | Manufacturer | Strip, Polishing Agent - Jazz Finishing Strip | 1 | 2008 |
| Wuxi Lyusmile Imp and Exp Co.,ltd | China | Private-label distributor | DENTAL POLISHING STRIP · Resin polishing strips · SS POLISHING STRIP · steel-STRIPROLL-RESIN | — | — |
| TitanLinks Logistics LLC | United States | Repacker / relabeler | Dental Instrument | — | — |
| Jmu Dental, Inc. | United States | Repacker / relabeler | EHM - STRIP, POLISHING AGENT | — | — |
| Soher Med Limited | Hong Kong SAR China | Foreign exporter | Polishing | — | — |
| STERIS Corporation | United States | Contract sterilizer | — | — | — |
| HSG-S Corp | United States | Manufacturer | — | — | — |
| Aspen Surgical Products | United States | Contract manufacturer | Symmetry Surgical | — | — |
| International Orthodontics Services. PC | United States | Repacker / relabeler | Abrasive Strip single / double fine and medium | — | — |
| Premium Plus Dental | United States | Lister | — | — | — |
| CARGUS International Inc. | United States | Repacker / relabeler | MARK3® White Stones | — | — |
| Unisource Shanghai Ltd. | China | Foreign exporter | Teeth Whitening Strips | — | — |
| First Dental Supplies LLC | United States | Repacker / relabeler | STRIP, POLISHING AGENT | — | — |
| Beaming White LLC | United States | Manufacturer | Beaming White | — | — |
| Ortho Solutions LC | United States | Contract manufacturer | — | — | — |
| Esthetic Orthodontic Company of America LLC | United States | Repacker / relabeler | IPR Handsaws | — | — |
| Signa Medical, Inc. | United States | Repacker / relabeler | Denmat Ceri-Sander | — | — |
| Sanicure BV | Netherlands | Foreign exporter | — | — | — |
| Double White Medical Technology Development(Guangzhou) Co. L | China | Foreign exporter | Charcoal Teeth Whitening Strips; CVSHealth Brilliant White Whitening Strips(Coconut flavor) · CVSHealth Brilliant White Whitening Strips(Peach flavor); Dissolving Teeth Whitening Strips · Fitreno Teeth Whitening Strips-ONG-YT-01; Teeth Whitening Dry Strips · Teeth Whitening Gel Strips; Teeth Whitening Strips,Teeth Whitening U-wraps | — | — |
| Guangzhou White Pro Oral Care Products Co., Ltd. | China | Foreign exporter | Charcoal Teeth Whitening Strips; CVSHealth Brilliant White Whitening Strips(Coconut flavor) · CVSHealth Brilliant White Whitening Strips(Peach flavor); Dissolving Teeth Whitening Strips · Fitreno Teeth Whitening Strips-ONG-YT-01; Teeth Whitening Dry Strips · Teeth Whitening Gel Strips; Teeth Whitening Strips,Teeth Whitening U-wraps | — | — |
| Peter Brasseler Holdings, LLC | United States | Contract manufacturer | VersaFlex Strip | — | — |
| Prais Reliable Dental Supplies S.A | Seychelles | Foreign exporter | — | — | — |
| Kash Sales Inc. | Canada | Foreign exporter | — | — | — |
| Mainline Medical Dental Supply | Canada | Foreign exporter | — | — | — |
| Oketz Logistics LLC | United States | Repacker / relabeler | — | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 28 May 1982 | K821364 | PROFLEX FLEXIBLE SCALER | Teledyne Densco |
| 21 May 1979 | K790598 | RUWA FINISHING STRIPS | Howmedica Corp. |
Official records: FDA product classification for EHM · 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