The following data is part of a premarket notification filed by Kulzer, Inc. with the FDA for Heraeus' Heragam 48, Non Gamma 2 Den. Amal. Alloy.
| Device ID | K875344 |
| 510k Number | K875344 |
| Device Name: | HERAEUS' HERAGAM 48, NON GAMMA 2 DEN. AMAL. ALLOY |
| Classification | Alloy, Amalgam |
| Applicant | KULZER, INC. 111 N. WABASH AVE. Chicago, IL 60602 |
| Contact | Bauer, Phd |
| Correspondent | Bauer, Phd KULZER, INC. 111 N. WABASH AVE. Chicago, IL 60602 |
| Product Code | EJJ |
| CFR Regulation Number | 872.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-12-30 |
| Decision Date | 1988-03-18 |