The following data is part of a premarket notification filed by Degussa Dental, Inc. with the FDA for Heraeus Dg 63.
| Device ID | K883509 |
| 510k Number | K883509 |
| Device Name: | HERAEUS DG 63 |
| Classification | Alloy, Other Noble Metal |
| Applicant | DEGUSSA DENTAL, INC. 21-25 44TH AVE. Long Island, NY 11101 |
| Contact | Josef Rothaut |
| Correspondent | Josef Rothaut DEGUSSA DENTAL, INC. 21-25 44TH AVE. Long Island, NY 11101 |
| Product Code | EJS |
| CFR Regulation Number | 872.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-08-17 |
| Decision Date | 1988-09-22 |