The following data is part of a premarket notification filed by Biomat Sciences, Inc. with the FDA for Adhere Conditioner, Adhere Primer, Adhere Lc Adhesive, Adhere Dc Adhere Dc Activator, Adhere Cylanate.
| Device ID | K992838 |
| 510k Number | K992838 |
| Device Name: | ADHERE CONDITIONER, ADHERE PRIMER, ADHERE LC ADHESIVE, ADHERE DC ADHERE DC ACTIVATOR, ADHERE CYLANATE |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | BIOMAT SCIENCES, INC. 5612 GLENWOOD RD. Bethesda, MD 20817 |
| Contact | Ivan Stangel |
| Correspondent | Ivan Stangel BIOMAT SCIENCES, INC. 5612 GLENWOOD RD. Bethesda, MD 20817 |
| Product Code | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-08-23 |
| Decision Date | 1999-11-15 |
| Summary: | summary |