The following data is part of a premarket notification filed by Degussa Ag with the FDA for Biolor.
Device ID | K921772 |
510k Number | K921772 |
Device Name: | BIOLOR |
Classification | Alloy, Gold-based Noble Metal |
Applicant | DEGUSSA AG 3950 SOUTH CLINTON AVE. South Plainfield, NJ 07080 |
Contact | Holger Meinicke |
Correspondent | Holger 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 | 1992-04-14 |
Decision Date | 1992-07-13 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
BIOLOR 97471815 not registered Live/Pending |
Bio Naturals, LLC 2022-06-23 |
BIOLOR 75876668 2501450 Dead/Cancelled |
DEGUDENT GMBH 1999-12-20 |