The following data is part of a premarket notification filed by Degussa Ag with the FDA for Degudent Gs.
Device ID | K905387 |
510k Number | K905387 |
Device Name: | DEGUDENT GS |
Classification | Alloy, Gold-based Noble Metal |
Applicant | DEGUSSA AG 3950 SOUTH CLINTON AVE. South Plainfield, NJ 07080 |
Contact | Meinicke |
Correspondent | Meinicke DEGUSSA AG 3950 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 | 1990-11-30 |
Decision Date | 1991-01-15 |