The following data is part of a premarket notification filed by Kerr Corporation (danbury) with the FDA for Kerr Optibond, Modification.
| Device ID | K934690 |
| 510k Number | K934690 |
| Device Name: | KERR OPTIBOND, MODIFICATION |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | KERR CORPORATION (DANBURY) 28200 WICK RD P.O. BOX 455 Romulus, MI 48174 |
| Contact | Benjamin Weaver |
| Correspondent | Benjamin Weaver KERR CORPORATION (DANBURY) 28200 WICK RD P.O. BOX 455 Romulus, MI 48174 |
| Product Code | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-07-26 |
| Decision Date | 1993-12-30 |