The following data is part of a premarket notification filed by Dr. Collins, Inc. with the FDA for Biomin Restore Plus.
| Device ID | K200077 |
| 510k Number | K200077 |
| Device Name: | BioMin Restore Plus |
| Classification | Varnish, Cavity |
| Applicant | Dr. Collins, Inc. 4330 Barranca Pkwy. Ste #100 Irvine, CA 92604 |
| Contact | Jiahe Li |
| Correspondent | Jiahe Li Dr. Collins, Inc. 4330 Barranca Pkwy. Ste #100 Irvine, CA 92604 |
| Product Code | LBH |
| CFR Regulation Number | 872.3260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-01-14 |
| Decision Date | 2020-11-06 |