The following data is part of a premarket notification filed by Sterngold/implamed with the FDA for Sternomega Temporary Cement Automix Ne, Model 220282/220281.
| Device ID | K984340 |
| 510k Number | K984340 |
| Device Name: | STERNOMEGA TEMPORARY CEMENT AUTOMIX NE, MODEL 220282/220281 |
| Classification | Cement, Dental |
| Applicant | STERNGOLD/IMPLAMED 23 FRANK MOSSBERG DR. Attleboro, MA 02703 -0967 |
| Contact | Gordon Nelson |
| Correspondent | Gordon Nelson STERNGOLD/IMPLAMED 23 FRANK MOSSBERG DR. Attleboro, MA 02703 -0967 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-12-04 |
| Decision Date | 1999-01-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841549100475 | K984340 | 000 |
| 00841549100468 | K984340 | 000 |