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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

CountryMakers
China14
United States10
Germany7
Brazil6
South Korea4
Japan2
Switzerland2
Hong Kong2
Sweden1
Israel1
Italy1
United Kingdom1
India1
Russia1

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.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
3R Industria E Comercio LtdaSao Paulo, BrazilManufacturer0000api.fda.gov
Abrasive Technology, LLCLewis Center, OH, United StatesManufacturer0000api.fda.gov
Ashtel Studios, Inc.Ontario, CA, United StatesSpecification developer0000api.fda.gov
Coltene/Whaledent GMBH & Co. KGLANGENAU Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Changsha Easyinsmile Intelligence Technology Co.Ltd.Changsha Hunan, ChinaManufacturer0000api.fda.gov
Dental Morelli Ltda.SOROCABA Sao Paulo, BrazilManufacturer0000api.fda.gov
DFL Industria E Comercio SARio de Janeiro, BrazilManufacturer0000api.fda.gov
Directa ABUPPLANDS VAESBY Stockholm, SwedenManufacturer0000api.fda.gov
Dome IncTarzana, CA, United StatesRemanufacturer0000api.fda.gov
DR. Hopf GMBH & Co. KGLANGENHAGEN Lower Saxony, GermanyManufacturer0000api.fda.gov
Dentaurum GmbH & Co. KGISPRINGEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Dentsply Sirona Orthodontics Inc.Sarasota, FL, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
E. C. Moore Company, Inc.Dearborn, MI, United StatesManufacturer0000api.fda.gov
Eve Ernst Vetter GMBHKeltern Baden-Wurttemberg, GermanyContract manufacturer, Manufacturer, Repackager or relabeler0000api.fda.gov
GARNET DENTECH CorpDaegu, South KoreaManufacturer0000api.fda.gov
GC Asahi CorporationAichi, JapanManufacturer0000api.fda.gov
Gebr. Brasseler GMBH & Co. KGLEMGO North Rhine-Westphalia, GermanyContract manufacturer, Manufacturer0000api.fda.gov
Guangxi Ehall Medical Technology Co.,ltdNanning Guangxi, ChinaExporter to the US, Manufacturer0000api.fda.gov
Hager & Meisinger GMBHNEUSS North Rhine-Westphalia, GermanyManufacturer0000api.fda.gov
Hangzhou Rollmed Co.,ltd.Hangzhou Zhejiang, ChinaManufacturer0000api.fda.gov
Hangzhou Wise Medical Device Co.,ltdHangzhou Zhejiang, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Henan Baistra Medical Devices LimitedZhengzhou Henan, ChinaExporter to the US, Manufacturer0000api.fda.gov
Hopf, Ringleb & Co. GMBH & Cie.Berlin, GermanyManufacturer0000api.fda.gov
Huanghua Promisee Dental Co., LtdHuanghua Hebei, ChinaManufacturer0000api.fda.gov
Indusbello Industria De Instrumentos OdoLondrina Parana, BrazilManufacturer0000api.fda.gov
Intensiv SACollina d'Oro / Montagnola Ticino, SwitzerlandManufacturer0000api.fda.gov
Integra LifeSciences Production CorporationMansfield, MA, United StatesManufacturer0000api.fda.gov
LLRN Personal Care (shenzhen) Co.,ltdshenzhen Guangdong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Maquira Industria De Produtos OdontologicosMaringa Parana, BrazilManufacturer0000api.fda.gov
MDT Micro Diamond Technologies LtdAFULA Northern, IsraelManufacturer0000api.fda.gov
Micerium S.P.A.AVEGNO Genova, ItalyManufacturer0000api.fda.gov
Microcopy, Division Of Neo-Flo, Inc.Kennesaw, GA, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Ortho Organizers, Inc.Savannah, GA, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
OSSTEM ORTHODONTICS Inc.Uiwang-si Gyeonggi, South KoreaManufacturer0000api.fda.gov
Osung MND Co., Ltd.Gimpo-si Gyeonggi, South KoreaManufacturer0000api.fda.gov
Onuge Personal Care (Guangdong) Manufacturer Group Co., LTD.Guangzhou Guangdong, ChinaManufacturer0000api.fda.gov
Premier Dental Products Co.Plymouth Meeting, PA, United StatesSpecification developer0000api.fda.gov
Prima Dental GroupGLOUCESTER Gloucestershire, United KingdomRepackager or relabeler, Specification developer0000api.fda.gov
Produits Dentaires SAVEVEY (SUISSE) Vaud, SwitzerlandManufacturer0000api.fda.gov
Premium Plus International LimitedHong Kong, Hong KongManufacturer0000api.fda.gov
Samson Innovation Corp. Ltd.Kowloon, Hong KongExporter to the US, Foreign private label distributor, Manufacturer, Specification developer0000api.fda.gov
Sawbros Industries Pvt LtdNOIDA Uttar Pradesh, IndiaManufacturer0000api.fda.gov
Shenzhen Denco Medical Co., Ltd.Shenzhen Guangdong, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Shenzhen Moye Technology Co LtdShenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Shenzhen Rogin Medical Co., Ltdshenzhen Guangdong, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Shofu Inc.FUKUINE, HIGASHIYAMA-KU Kyoto, JapanManufacturer0000api.fda.gov
Tangshan Zhengtong Exhibition Co., Ltd.Tangshan Hebei, ChinaManufacturer0000api.fda.gov
TDV Dental LtdaPOMERODE Santa Catarina, BrazilContract manufacturer, Manufacturer0000api.fda.gov
Tor VM Ltd.Moscow Moskva, RussiaManufacturer0000api.fda.gov
TP Orthodontics, Inc.La Porte, IN, United StatesManufacturer0000api.fda.gov
Weihai Jieshi Commodity Manufacture Co. Ltd.Weihai,Shandong, ChinaManufacturer0000api.fda.gov
World Bio Tech Co LtdSeongnam-si Gyeonggi, South KoreaManufacturer0000api.fda.gov
Wuxi TP Orthodontics Material Co., Ltd.WUXI Jiangsu, ChinaManufacturer0000api.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.