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 |