Manufacturer registered with FDA
DFS-Diamon GmbH
RIEDENBURG, Germany. Lists 6 dental device types with FDA across 1 registered establishment.
- Device types listed
- 6
- Brands and models
- 47
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1374 registrations outside the US
- Establishments
- 1Germany
Registered in 13 markets
Where regulators' registries name DFS-Diamon GmbH as the manufacturer or the registration holder of a device.
RegisteredHome: GermanyOne marker per market
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | DFS-Diamon GmbH | 6 device types | — | Below |
| Saudi Arabia | SFDA | Manufacturer | DFS-Diamon GmbH | 29 | — | Pure Global AI |
| Colombia | INVIMA | Manufacturer | DFS DIAMON GMBHDFS - DIAMON GMBH | 18 | — | Pure Global AI |
| Serbia | ALIMS | Manufacturer | DFS-DIAMON GmbH | 8 | 2024–2024 | Pure Global AI |
| South Korea | MFDS | Manufacturer | DFS-DIAMON GmbH | 5 | 2012–2013 | Pure Global AI |
| Australia | TGA | Manufacturer | DFS-Diamon GmbH | 2 | 2023–2026 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | DFS-DIAMON GMBH | 2 | 2007–2024 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | DFS-Diamon GmbH | 2 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | DFS DiamonDFS-Diamon GmbH | 2 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | DFS DIAMON GMBH | 2 | 2017–2026 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | DFS-DIAMON GmbH | 2 | — | Pure Global AI |
| China | NMPA | Registration holder | 德国迪福士-德蒙有限公司DFS-DIAMON GmbH | 1 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | DFS-DIAMON GmbH | 1 | 2021–2021 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What DFS-Diamon GmbH currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Dental Diamond InstrumentDZP · Class 1 | Dental burs & diamonds | Maker | 200147 Finishing & polishing kit ceramics/composites50500 REDUCERS HP, pu: 2pcs50510 REDUCERS CA, pu: 2 pcs50520 REDUCERS HP-FG 1,6 mm, pu: 2 pcs800209 ZIRCONIA TOOL KIT80023 Circopol A80024 Circopol B800559 Polisher Durocomp large torpedo CA, pu: 6 pcs800569 Polisher Durocomp small torpedo CA, pu: 6 pcs800579 Polisher Durocomp lense CA, pu: 6 pcs 37 more800589 Polisher Durocomp cup CA, pu: 6 pcs800616 2ceram polisher flame CA, pu: 6 pcs800626 2ceram polisher cup CA, pu: 6 pcs800636 2ceram polisher lense CA, pu: 6 pcs800646 2ceram polisher flame CA, pu: 6 pcs800656 2ceram polisher cup CA, pu: 6 pcs800666 2ceram polisher lense CA, pu: 6 pcs800676 2comp polishers small point CA, pu: 6 pcs800686 2comp polishers cup CA, pu: 6 pcs800696 2comp polishers lense CA, pu: 6 pcs800759 Polisher Durocomp large torpedo CA, pu: 6 pcs800769 Polisher Durocomp small torpedo CA, pu: 6 pcs800779 Polisher Durocomp lense CA, pu: 6 pcs800789 Polisher Durocomp cup CA, pu: 6 pcs800806 2comp polishers point CA, pu: 6 pcs800816 2comp polishers small point CA, pu: 6 pcs800826 2comp polishers cup CA, pu: 6 pcs800836 2comp polishers lense CA, pu: 6 pcs800846 2comp polisher point CA, pu: 6 pcs80099 DIAFIX ORAL 9 mm x 3 mm, pu: 12 pcs mounted800997 DIAFIX ORAL 9 mm x 3 mm, pu: 50 pcs + 2 mandrels801909 UPORAL D Set, pu: 2 pcs assorted801980UD Uporal D cup polisher 61029801989 UPORAL D cup, pu: 2 pcs801990UD Uporal D point polisher 61032801999 UPORAL D, pu: 2 pcs803506 2ceram polisher flame FG, pu: 6 pcs803516 2ceram polishers cup CA, pu: 6 pcs803526 2ceram polishers flame FG, pu: 6 pcs803536 2ceram polisher cup FG, pu: 6 pcs803546 2comp polishers small point FG, pu: 6 pcs803556 2comp polishers small point FG, pu: 6 pcs81099 DIAFIX ORAL 9 mm x 1,5 mm, pu: 12 pcs mounted810997 DIAFIX ORAL 9 mm x 1,5 mm, pu: 50 pcs82099 DIAFIX ORAL Set, pu: 6 pcs assorted999000 RTS Intro-Set C999002 RTS Intro-Set D | 1997 |
| Abrasive DiskEHJ · Class 1 | Polishing & prophylaxis | Maker | — | 1997 |
| Abrasive PointEHL · Class 1 | Polishing & prophylaxis | Maker | — | 1997 |
| Base Metal AlloyEJH · Class 2 | Dental alloys | Maker | — | 2009 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Maker | — | 1997 |
| Polishing Agent WheelEJQ · Class 1 | Polishing & prophylaxis | Maker | — | 2015 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| DFS-DIAMON GMBHFDA reg. 9614948 | RIEDENBURG Bavaria, Germany | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9031482). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.