The following data is part of a premarket notification filed by Degussa Ag with the FDA for Degussa Stopfgold (degussa Direct-filling Gold).
| Device ID | K902387 |
| 510k Number | K902387 |
| Device Name: | DEGUSSA STOPFGOLD (DEGUSSA DIRECT-FILLING GOLD) |
| Classification | Alloy, Gold-based Noble Metal |
| Applicant | DEGUSSA AG POSTFACH 110533 D-6000 FRANKFURT 11 West Germany, DE |
| Contact | Mackert |
| Correspondent | Mackert DEGUSSA AG POSTFACH 110533 D-6000 FRANKFURT 11 West Germany, DE |
| Product Code | EJT |
| CFR Regulation Number | 872.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-05-30 |
| Decision Date | 1990-06-28 |