The following data is part of a premarket notification filed by Gramm Surface Technology, Inc. with the FDA for Gammat Electroformed Gold Coping.
| Device ID | K911042 |
| 510k Number | K911042 |
| Device Name: | GAMMAT ELECTROFORMED GOLD COPING |
| Classification | Alloy, Gold-based Noble Metal |
| Applicant | GRAMM SURFACE TECHNOLOGY, INC. 15763 EDGEWOOD DR. Dumfries, VA 22026 |
| Contact | Katharina G Everett |
| Correspondent | Katharina G Everett GRAMM SURFACE TECHNOLOGY, INC. 15763 EDGEWOOD DR. Dumfries, VA 22026 |
| Product Code | EJT |
| CFR Regulation Number | 872.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-08 |
| Decision Date | 1991-05-29 |