The following data is part of a premarket notification filed by Degussa Dental, Inc. with the FDA for Albabond 60.
Device ID | K883758 |
510k Number | K883758 |
Device Name: | ALBABOND 60 |
Classification | Alloy, Gold-based 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 | EJT |
CFR Regulation Number | 872.3060 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-09-06 |
Decision Date | 1988-10-12 |