Not currently registered with FDA under this name
Phoenix Dental, Inc.
Fenton, MI, United States. Named as applicant on 5 dental 510(k) clearances between 1994 and 2012. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 51994–2012
- Markets registered in
- 21 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 1990–2026
Registered in 2 markets
Where regulators' registries name Phoenix Dental, Inc. 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 | Phoenix Dental, Inc. | 5 clearances | 1994–2012 | Below |
| Israel | AMAR | Manufacturer | Phoenix Dental Inc | 1 | — | 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 Phoenix Dental, Inc. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 7 Mar 2012 | K120109 | SUPER SEAL TOOTH DESENSITIZER | LBH Cavity Varnish |
| 11 Mar 2011 | K102821 | DISCOVRED | LFC Caries Detection Device |
| 22 Dec 1998 | K983477 | SUPER SEAL | EJK Calcium Hydroxide Cavity Liner |
| 23 Jun 1994 | K926101 | PHOENIX OPTI-MAX DENT IMPL W/PLAS-SPRAY TITA/HYDRO | DZE Root-Form Endosseous Implant |
| 22 Jun 1994 | K926102 | PHOENIX OPTI-MAX DENT IMPLANT W/PLASMA-SPRAY TITAN | DZE Root-Form Endosseous Implant |
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.