Not currently registered with FDA under this name
Dentaurum
Newtown, PA, United States. Named as applicant on 10 dental 510(k) clearances between 2001 and 2006. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 102001–2006
- Markets registered in
- 326 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 2000–2026
Registered in 3 markets
Where regulators' registries name Dentaurum as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Applicant | Dentaurum | 10 clearances | 2001–2006 | Below |
| South Korea | MFDS | Manufacturer | DentaurumDENTAURUM | 22 | 1998–2006 | Pure Global AI |
| Colombia | INVIMA | Registration holder | DENTAURUM | 4 | — | 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
510(k) clearances
Clearances on which FDA names Dentaurum as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 9 Nov 2006 | K062733 | TOMAS PIN SD 6, 8, AND 10 MM | OAT Orthodontic Endosseous Implant |
| 25 Oct 2006 | K062732 | TOMAS PIN 6 MM | OAT Orthodontic Endosseous Implant |
| 15 Apr 2005 | K042965 | TOMAS PIN | OAT Orthodontic Endosseous Implant |
| 21 Nov 2003 | K030644 | CONTEC DUO, CONTEC LC, CONTEC LCR | DYH Resin Bracket and Tooth Conditioner Adhesive |
| 7 Oct 2003 | K032195 | DENTAURUM GLASTEC DENTAL ORTHODONTIC CEMENT | DYH Resin Bracket and Tooth Conditioner Adhesive |
| 25 Aug 2003 | K030980 | DENTAURUM NO-MIX ONE STEP BRACKET ADHESIVE | DYH Resin Bracket and Tooth Conditioner Adhesive |
| 25 Aug 2003 | K030977 | DENTAURUM MIX TWO-PASTE BRACKET ADHESIVE | DYH Resin Bracket and Tooth Conditioner Adhesive |
| 10 Jun 2003 | K030641 | CONTEC LIGHT | EBZ Ultraviolet Activator for Polymerization |
| 5 Jun 2001 | K011428 | TRICERAM | EIH Porcelain Powder |
| 5 Jun 2001 | K011425 | CARMEN | EIH Porcelain Powder |
Some of these clearances are listed with FDA today by another company: Dentaurum GmbH & Co. KG (4), Specialty Appliances, LLC (1).
Sources
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 of the most recent filing, which can be a US agent.