The following data is part of a premarket notification filed by Sterngold/implamed with the FDA for Sternomega Bonding Agent, Sternomega Composite Lc, Sternomega Compomer Lc.
| Device ID | K982692 |
| 510k Number | K982692 |
| Device Name: | STERNOMEGA BONDING AGENT, STERNOMEGA COMPOSITE LC, STERNOMEGA COMPOMER LC |
| Classification | Material, Tooth Shade, Resin |
| Applicant | STERNGOLD/IMPLAMED 50 BREWSTER ST. Pawtucket, RI 02860 |
| Contact | Pamela Papineau |
| Correspondent | Pamela Papineau STERNGOLD/IMPLAMED 50 BREWSTER ST. Pawtucket, RI 02860 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-08-03 |
| Decision Date | 1998-10-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E21728411L1 | K982692 | 000 |
| E21728415S1 | K982692 | 000 |
| E21728421L1 | K982692 | 000 |
| E21728421M1 | K982692 | 000 |
| E21728421S1 | K982692 | 000 |
| E21728422L1 | K982692 | 000 |
| E21728422M1 | K982692 | 000 |
| E21728422S1 | K982692 | 000 |
| E21728423L1 | K982692 | 000 |
| E21728423M1 | K982692 | 000 |
| E21728423S1 | K982692 | 000 |
| E21728424L1 | K982692 | 000 |
| E21728424M1 | K982692 | 000 |
| E21728424S1 | K982692 | 000 |
| E21728415M1 | K982692 | 000 |
| E21728415L1 | K982692 | 000 |
| E21728414S1 | K982692 | 000 |
| E21728411M1 | K982692 | 000 |
| E21728411S1 | K982692 | 000 |
| E21728412L1 | K982692 | 000 |
| E21728412M1 | K982692 | 000 |
| E21728412S1 | K982692 | 000 |
| E2172841323L1 | K982692 | 000 |
| E2172841323M1 | K982692 | 000 |
| E2172841323S1 | K982692 | 000 |
| E21728413L1 | K982692 | 000 |
| E21728413M1 | K982692 | 000 |
| E21728413S1 | K982692 | 000 |
| E21728414L1 | K982692 | 000 |
| E21728414M1 | K982692 | 000 |
| E21728425L1 | K982692 | 000 |
| E21728425M1 | K982692 | 000 |
| E21728442S1 | K982692 | 000 |
| E21728443M1 | K982692 | 000 |
| E21728443S1 | K982692 | 000 |
| E21728444M1 | K982692 | 000 |
| E21728444S1 | K982692 | 000 |
| E21728445M1 | K982692 | 000 |
| E21728445S1 | K982692 | 000 |
| E217284501 | K982692 | 000 |
| E217284511 | K982692 | 000 |
| E217284521 | K982692 | 000 |
| E217284531 | K982692 | 000 |
| E217284541 | K982692 | 000 |
| E217284551 | K982692 | 000 |
| E21728442M1 | K982692 | 000 |
| E21728441S1 | K982692 | 000 |
| E21728441M1 | K982692 | 000 |
| E21728425S1 | K982692 | 000 |
| E21728431M1 | K982692 | 000 |
| E21728431S1 | K982692 | 000 |
| E21728432M1 | K982692 | 000 |
| E21728432S1 | K982692 | 000 |
| E2172843343M1 | K982692 | 000 |
| E2172843343S1 | K982692 | 000 |
| E21728433M1 | K982692 | 000 |
| E21728433S1 | K982692 | 000 |
| E21728434M1 | K982692 | 000 |
| E21728434S1 | K982692 | 000 |
| E21728435M1 | K982692 | 000 |
| E21728435S1 | K982692 | 000 |
| E217284561 | K982692 | 000 |