Data / Medical devices / Strip, Polishing Agent
Strip, Polishing Agent (EHM): 53 FDA-registered makers in 14 countries
53 establishments in 14 countries are registered with the FDA to make Strip, Polishing Agent (product code EHM, Class 1, 21 CFR 872.6010). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 2 510(k) clearances under this code, the latest on May 28, 1982, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- EHM
- Device class
- 1
- Regulation
- 872.6010
- Medical specialty
- Dental
Makers by country
| Country | Makers |
|---|---|
| China | 14 |
| United States | 10 |
| Germany | 7 |
| Brazil | 6 |
| South Korea | 4 |
| Japan | 2 |
| Switzerland | 2 |
| Hong Kong | 2 |
| Sweden | 1 |
| Israel | 1 |
| Italy | 1 |
| United Kingdom | 1 |
| India | 1 |
| Russia | 1 |
Makers of Strip, Polishing Agent
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| 3R Industria E Comercio Ltda | Sao Paulo, Brazil | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Abrasive Technology, LLC | Lewis Center, OH, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ashtel Studios, Inc. | Ontario, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Coltene/Whaledent GMBH & Co. KG | LANGENAU Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Changsha Easyinsmile Intelligence Technology Co.Ltd. | Changsha Hunan, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dental Morelli Ltda. | SOROCABA Sao Paulo, Brazil | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| DFL Industria E Comercio SA | Rio de Janeiro, Brazil | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Directa AB | UPPLANDS VAESBY Stockholm, Sweden | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dome Inc | Tarzana, CA, United States | Remanufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| DR. Hopf GMBH & Co. KG | LANGENHAGEN Lower Saxony, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dentaurum GmbH & Co. KG | ISPRINGEN Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dentsply Sirona Orthodontics Inc. | Sarasota, FL, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| E. C. Moore Company, Inc. | Dearborn, MI, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Eve Ernst Vetter GMBH | Keltern Baden-Wurttemberg, Germany | Contract manufacturer, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| GARNET DENTECH Corp | Daegu, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GC Asahi Corporation | Aichi, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gebr. Brasseler GMBH & Co. KG | LEMGO North Rhine-Westphalia, Germany | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangxi Ehall Medical Technology Co.,ltd | Nanning Guangxi, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hager & Meisinger GMBH | NEUSS North Rhine-Westphalia, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hangzhou Rollmed Co.,ltd. | Hangzhou Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hangzhou Wise Medical Device Co.,ltd | Hangzhou Zhejiang, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Henan Baistra Medical Devices Limited | Zhengzhou Henan, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hopf, Ringleb & Co. GMBH & Cie. | Berlin, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Huanghua Promisee Dental Co., Ltd | Huanghua Hebei, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Indusbello Industria De Instrumentos Odo | Londrina Parana, Brazil | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Intensiv SA | Collina d'Oro / Montagnola Ticino, Switzerland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Integra LifeSciences Production Corporation | Mansfield, MA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| LLRN Personal Care (shenzhen) Co.,ltd | shenzhen Guangdong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Maquira Industria De Produtos Odontologicos | Maringa Parana, Brazil | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MDT Micro Diamond Technologies Ltd | AFULA Northern, Israel | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Micerium S.P.A. | AVEGNO Genova, Italy | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Microcopy, Division Of Neo-Flo, Inc. | Kennesaw, GA, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ortho Organizers, Inc. | Savannah, GA, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| OSSTEM ORTHODONTICS Inc. | Uiwang-si Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Osung MND Co., Ltd. | Gimpo-si Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Onuge Personal Care (Guangdong) Manufacturer Group Co., LTD. | Guangzhou Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Premier Dental Products Co. | Plymouth Meeting, PA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Prima Dental Group | GLOUCESTER Gloucestershire, United Kingdom | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Produits Dentaires SA | VEVEY (SUISSE) Vaud, Switzerland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Premium Plus International Limited | Hong Kong, Hong Kong | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Samson Innovation Corp. Ltd. | Kowloon, Hong Kong | Exporter to the US, Foreign private label distributor, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sawbros Industries Pvt Ltd | NOIDA Uttar Pradesh, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Denco Medical Co., Ltd. | Shenzhen Guangdong, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Moye Technology Co Ltd | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Rogin Medical Co., Ltd | shenzhen Guangdong, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shofu Inc. | FUKUINE, HIGASHIYAMA-KU Kyoto, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tangshan Zhengtong Exhibition Co., Ltd. | Tangshan Hebei, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| TDV Dental Ltda | POMERODE Santa Catarina, Brazil | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tor VM Ltd. | Moscow Moskva, Russia | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| TP Orthodontics, Inc. | La Porte, IN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Weihai Jieshi Commodity Manufacture Co. Ltd. | Weihai,Shandong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| World Bio Tech Co Ltd | Seongnam-si Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wuxi TP Orthodontics Material Co., Ltd. | WUXI Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated May 28, 1982. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.