Not currently registered with FDA under this name
Sterngold/Implamed
Attleboro, MA, United States. Named as applicant on 16 dental 510(k) clearances between 1992 and 1999. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 161992–1999
- Markets registered in
- 29 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 1990–2026
Registered in 2 markets
Where regulators' registries name Sterngold/Implamed 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 | Sterngold/Implamed | 16 clearances | 1992–1999 | Below |
| South Korea | MFDS | Manufacturer | Sterngold ImplaMed | 9 | 1999–2000 | 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 Sterngold/Implamed as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 8 Jan 1999 | K984341 | STERNVANTAGE VARNISH LC, MODEL 221001 | EBI Rebasing Repairing Relining Denture Resin |
| 8 Jan 1999 | K984340 | STERNOMEGA TEMPORARY CEMENT AUTOMIX NE, MODEL 220282/220281 | EMA Dental Cement |
| 13 Nov 1998 | K983786 | STERNGOLD IMPLAMED WIDE PLATFORM DENTAL IMPLANTS AND RELATED PROSTHETICS AND INSTTUMENTATION | DZE Root-Form Endosseous Implant |
| 22 Oct 1998 | K982692 | STERNOMEGA BONDING AGENT, STERNOMEGA COMPOSITE LC, STERNOMEGA COMPOMER LC | EBF Resin Tooth Shade Material |
| 9 Oct 1998 | K982895 | STERNOMEGA COMPOMER CEMENT | EMA Dental Cement |
| 11 May 1998 | K981516 | STERNGOLD IMPLAMED HEX SCREW IMPLANT TPS COATED STERNGOLD IMPLAMED HEX SCREW IMPLANT HA COATED , REFER TO TABLE 1 IN SUB | DZE Root-Form Endosseous Implant |
| 24 Jul 1996 | K962326 | STERNGOLD BIO-5 (1127210) | EJT Gold-Based Noble Metal Alloy |
| 24 Jul 1996 | K962325 | QUASAR YELLOW CROWN AND BRIDGE ALLOY (1122015) | EJT Gold-Based Noble Metal Alloy |
| 24 Jul 1996 | K962324 | STERNGOLD U-CPF METAL ALLOY (1067800) | EJS Alloy Other Noble Metal |
| 23 Jul 1996 | K962304 | STERNGOLD BIO-4 | EJS Alloy Other Noble Metal |
| 18 Jul 1996 | K962303 | STERNGOLD CF | EJT Gold-Based Noble Metal Alloy |
| 18 Jul 1996 | K962302 | PEGASUS DENTAL ALLOY | EJT Gold-Based Noble Metal Alloy |
| 29 May 1996 | K960956 | STERNGOLD M-PF YELLOW CROWN & BRIDGE ALLOY MODEL 1127200 | EJT Gold-Based Noble Metal Alloy |
| 23 Mar 1995 | K950213 | THE STERN ROOT ANCHOR SYSTEM | ELR Root Canal Post |
| 30 Jan 1992 | K913348 | THE STERN ERA SYSTEM | DZE Root-Form Endosseous Implant |
| 17 Jan 1992 | K914764 | STERN ERA IMPLANT ABUTMENT | DZE Root-Form Endosseous Implant |
Some of these clearances are listed with FDA today by another company: Sterngold (14), indigodental GmbH (2), DMG Chemisch-Pharmazeutische Fabrik GmbH (2).
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.