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
| Country | Makers |
|---|---|
| United States | 22 |
| Germany | 10 |
| China | 4 |
| Brazil | 3 |
| Switzerland | 3 |
| Italy | 2 |
| Japan | 2 |
| Pakistan | 1 |
| Liechtenstein | 1 |
| Israel | 1 |
| Canada | 1 |
| France | 1 |
| Taiwan | 1 |
| Vietnam | 1 |
| Czechia | 1 |
| Russia | 1 |
| South Korea | 1 |
| India | 1 |
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.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Centrix, Inc. | Shelton, CT, United States | Manufacturer | 1 | August 17, 1987 | 0 | 0 | 0 | api.fda.gov |
| 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 | |
| BUSCH & CO. GmbH & Co. KG | ENGELSKIRCHEN North Rhine-Westphalia, Germany | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Coltene/Whaledent AG | ALTSTAETTEN Sankt Gallen, Switzerland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dentsply LLC | Milford, DE, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dfs-Diamon GMBH | RIEDENBURG Bavaria, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Diaswiss S.A. | NYON Vaud, Switzerland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| DR. Hopf GMBH & Co. KG | LANGENHAGEN Lower Saxony, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dedeco International, Inc. | Long Eddy, NY, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dentaurum GmbH & Co. KG | ISPRINGEN Baden-Wurttemberg, Germany | Manufacturer | 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 | |
| EverBrands, Inc. | Garden Grove, CA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Falcon Surgical Co. (Pvt.) Ltd. | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fischer Surgical Inc. | Imperial, MO, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Garrison Dental Solutions | Spring Lake, MI, United States | Complaint file establishment, 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 | |
| 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 | |
| Ivoclar Vivadent AG | Schaan, Liechtenstein | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Integra LifeSciences Production Corporation | Mansfield, MA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jordco, Inc. | Hillsboro, OR, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Josef Ganter Feinmechanik GMBH | DAUCHINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jota AG | RUETHI, SG Sankt Gallen, Switzerland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kerr Corporation | Pomona, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kerr Italia, S.r.l. | SCAFATI Salerno, Italy | 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 | |
| Onvet Medical Canada Inc | TORONTO Ontario, Canada | 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 | |
| PHS Do Brasil Ltda | Joinville Santa Catarina, Brazil | 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 | |
| Premier Medical | Philadelphia, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Prismatik Dentalcraft, Inc. | Irvine, CA, United States | Complaint file establishment, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Prodont-Holliger S.A.S. | OLLIERGUES Puy-de-Dome, France | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Prismatik Dentalcraft, Inc. | Irvine, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Reco-Dent Intl. Co., Ltd. | New Taipei City, Taiwan | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai Dochem Industries Co., Ltd. | Shanghai, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai Shofu Dental Material Co. Ltd | Shanghai, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shofu Inc. | FUKUINE, HIGASHIYAMA-KU Kyoto, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shofu Products Kyoto Inc. | Kyoto, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shofu Products Vietnam Co., Ltd | Dong Van Ward Ninh Binh, Vietnam | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Solventum Us LLC | Eagan, MN, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai Toboom Dental Techonology CO., LTD. | Shanghai, China | Contract manufacturer, Exporter to the US, Foreign private label distributor, Manufacturer, Remanufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Solventum Germany GmbH | SEEFELD Bavaria, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Solventum US LLC | San Antonio, TX, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Solventum US LLC | Irvine, CA, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| SpofaDental a.s. | Jicin, Czechia | Contract 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 | |
| Teleflex LLC (NADC) | Olive Branch, MS, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Teleflex Medical LLC | Morrisville, NC, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vericom Co., Ltd. | Chuncheon-Si Gangwon, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Voco GMBH | CUXHAVEN Lower Saxony, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zentro Enterprise Pvt Ltd | RAJKOT Gujarat, India | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.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.