The following data is part of a premarket notification filed by Degussa Corp. with the FDA for Primallor 1.
| Device ID | K951784 |
| 510k Number | K951784 |
| Device Name: | PRIMALLOR 1 |
| Classification | Alloy, Gold-based Noble Metal |
| Applicant | DEGUSSA CORP. 3900 SOUTH CLINTON AVE. South Plainfield, NJ 07080 |
| Contact | M Einicke |
| Correspondent | M Einicke DEGUSSA CORP. 3900 SOUTH CLINTON AVE. South Plainfield, NJ 07080 |
| Product Code | EJT |
| CFR Regulation Number | 872.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-04-17 |
| Decision Date | 1995-06-06 |