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Data / Medical devices / Disk, Abrasive

Disk, Abrasive (EHJ): 57 FDA-registered makers in 18 countries

57 establishments in 18 countries are registered with the FDA to make Disk, Abrasive (product code EHJ, Class 1, 21 CFR 872.6010). 1 of them has a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 4 510(k) clearances under this code, the latest on November 19, 1991, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Product code
EHJ
Device class
1
Regulation
872.6010
Medical specialty
Dental

Makers by country

CountryMakers
United States22
Germany10
China4
Brazil3
Switzerland3
Italy2
Japan2
Pakistan1
Liechtenstein1
Israel1
Canada1
France1
Taiwan1
Vietnam1
Czechia1
Russia1
South Korea1
India1

Makers of Disk, Abrasive

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
Centrix, Inc.Shelton, CT, United StatesManufacturer1August 17, 1987000api.fda.gov
3R Industria E Comercio LtdaSao Paulo, BrazilManufacturer0000api.fda.gov
Abrasive Technology, LLCLewis Center, OH, United StatesManufacturer0000api.fda.gov
BUSCH & CO. GmbH & Co. KGENGELSKIRCHEN North Rhine-Westphalia, GermanyContract manufacturer, Manufacturer0000api.fda.gov
Coltene/Whaledent AGALTSTAETTEN Sankt Gallen, SwitzerlandManufacturer0000api.fda.gov
Dentsply LLCMilford, DE, United StatesManufacturer0000api.fda.gov
Dfs-Diamon GMBHRIEDENBURG Bavaria, GermanyManufacturer0000api.fda.gov
Diaswiss S.A.NYON Vaud, SwitzerlandManufacturer0000api.fda.gov
DR. Hopf GMBH & Co. KGLANGENHAGEN Lower Saxony, GermanyManufacturer0000api.fda.gov
Dedeco International, Inc.Long Eddy, NY, United StatesManufacturer0000api.fda.gov
Dentaurum GmbH & Co. KGISPRINGEN Baden-Wurttemberg, GermanyManufacturer0000api.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
EverBrands, Inc.Garden Grove, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Falcon Surgical Co. (Pvt.) Ltd.Sialkot Punjab, PakistanManufacturer0000api.fda.gov
Fischer Surgical Inc.Imperial, MO, United StatesManufacturer0000api.fda.gov
Garrison Dental SolutionsSpring Lake, MI, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Gebr. Brasseler GMBH & Co. KGLEMGO North Rhine-Westphalia, GermanyContract manufacturer, Manufacturer0000api.fda.gov
Hopf, Ringleb & Co. GMBH & Cie.Berlin, GermanyManufacturer0000api.fda.gov
Huanghua Promisee Dental Co., LtdHuanghua Hebei, ChinaManufacturer0000api.fda.gov
Ivoclar Vivadent AGSchaan, LiechtensteinSpecification developer0000api.fda.gov
Integra LifeSciences Production CorporationMansfield, MA, United StatesSpecification developer0000api.fda.gov
Jordco, Inc.Hillsboro, OR, United StatesManufacturer0000api.fda.gov
Josef Ganter Feinmechanik GMBHDAUCHINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Jota AGRUETHI, SG Sankt Gallen, SwitzerlandContract manufacturer0000api.fda.gov
Kerr CorporationPomona, CA, United StatesManufacturer0000api.fda.gov
Kerr Italia, S.r.l.SCAFATI Salerno, ItalyManufacturer0000api.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
Onvet Medical Canada IncTORONTO Ontario, CanadaManufacturer0000api.fda.gov
Ortho Organizers, Inc.Savannah, GA, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
PHS Do Brasil LtdaJoinville Santa Catarina, BrazilManufacturer0000api.fda.gov
Premier Dental Products Co.Plymouth Meeting, PA, United StatesSpecification developer0000api.fda.gov
Premier MedicalPhiladelphia, PA, United StatesContract manufacturer0000api.fda.gov
Prismatik Dentalcraft, Inc.Irvine, CA, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler0000api.fda.gov
Prodont-Holliger S.A.S.OLLIERGUES Puy-de-Dome, FranceManufacturer0000api.fda.gov
Prismatik Dentalcraft, Inc.Irvine, CA, United StatesManufacturer0000api.fda.gov
Reco-Dent Intl. Co., Ltd.New Taipei City, TaiwanExporter to the US, Manufacturer0000api.fda.gov
Shanghai Dochem Industries Co., Ltd.Shanghai, ChinaManufacturer0000api.fda.gov
Shanghai Shofu Dental Material Co. LtdShanghai, ChinaManufacturer0000api.fda.gov
Shofu Inc.FUKUINE, HIGASHIYAMA-KU Kyoto, JapanManufacturer0000api.fda.gov
Shofu Products Kyoto Inc.Kyoto, JapanManufacturer0000api.fda.gov
Shofu Products Vietnam Co., LtdDong Van Ward Ninh Binh, VietnamManufacturer0000api.fda.gov
Solventum Us LLCEagan, MN, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Shanghai Toboom Dental Techonology CO., LTD.Shanghai, ChinaContract manufacturer, Exporter to the US, Foreign private label distributor, Manufacturer, Remanufacturer, Repackager or relabeler0000api.fda.gov
Solventum Germany GmbHSEEFELD Bavaria, GermanyManufacturer0000api.fda.gov
Solventum US LLCSan Antonio, TX, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Solventum US LLCIrvine, CA, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
SpofaDental a.s.Jicin, CzechiaContract manufacturer0000api.fda.gov
TDV Dental LtdaPOMERODE Santa Catarina, BrazilContract manufacturer, Manufacturer0000api.fda.gov
Tor VM Ltd.Moscow Moskva, RussiaManufacturer0000api.fda.gov
Teleflex LLC (NADC)Olive Branch, MS, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Teleflex Medical LLCMorrisville, NC, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Vericom Co., Ltd.Chuncheon-Si Gangwon, South KoreaManufacturer0000api.fda.gov
Voco GMBHCUXHAVEN Lower Saxony, GermanyManufacturer0000api.fda.gov
Zentro Enterprise Pvt LtdRAJKOT Gujarat, IndiaManufacturer, Repackager or relabeler0000api.fda.gov

Updated November 19, 1991. 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.