Sterngold/Implamed
Attleboro, MA, US
Sterngold/Implamed appears in FDA device records in Attleboro, MA. FDA records list 16 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 16
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 16 510(k) clearances for Sterngold/Implamed between 1992 and 1999. The busiest year on record is 1996, with 7. The most recent is 1999, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1992 | 2 |
| 1995 | 1 |
| 1996 | 7 |
| 1998 | 4 |
| 1999 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K984341 | STERNVANTAGE VARNISH LC, MODEL 221001 | EBI | Substantially Equivalent | |
| K984340 | STERNOMEGA TEMPORARY CEMENT AUTOMIX NE, MODEL 220282/220281 | EMA | Substantially Equivalent | |
| K983786 | STERNGOLD IMPLAMED WIDE PLATFORM DENTAL IMPLANTS AND RELATED PROSTHETICS AND INSTTUMENTATION | DZE | Substantially Equivalent | |
| K982692 | STERNOMEGA BONDING AGENT, STERNOMEGA COMPOSITE LC, STERNOMEGA COMPOMER LC | EBF | Substantially Equivalent | |
| K982895 | STERNOMEGA COMPOMER CEMENT | EMA | Substantially Equivalent | |
| K981516 | STERNGOLD IMPLAMED HEX SCREW IMPLANT TPS COATED STERNGOLD IMPLAMED HEX SCREW IMPLANT HA COATED , REFER TO TABLE 1 IN SUB | DZE | Substantially Equivalent | |
| K962326 | STERNGOLD BIO-5 (1127210) | EJT | Substantially Equivalent | |
| K962325 | QUASAR YELLOW CROWN AND BRIDGE ALLOY (1122015) | EJT | Substantially Equivalent | |
| K962324 | STERNGOLD U-CPF METAL ALLOY (1067800) | EJS | Substantially Equivalent | |
| K962304 | STERNGOLD BIO-4 | EJS | Substantially Equivalent | |
| K962303 | STERNGOLD CF | EJT | Substantially Equivalent | |
| K962302 | PEGASUS DENTAL ALLOY | EJT | Substantially Equivalent | |
| K960956 | STERNGOLD M-PF YELLOW CROWN & BRIDGE ALLOY MODEL 1127200 | EJT | Substantially Equivalent | |
| K950213 | THE STERN ROOT ANCHOR SYSTEM | ELR | Substantially Equivalent | |
| K913348 | THE STERN ERA SYSTEM | DZE | Substantially Equivalent | |
| K914764 | STERN ERA IMPLANT ABUTMENT | DZE | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain