The following data is part of a premarket notification filed by Confi-dental Products Co. with the FDA for Confi-bond.
| Device ID | K955328 |
| 510k Number | K955328 |
| Device Name: | CONFI-BOND |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | CONFI-DENTAL PRODUCTS CO. 416 SOUTH TAYLOR AVE. Louisville, CO 80027 -3028 |
| Contact | Sharon A Lutton |
| Correspondent | Sharon A Lutton CONFI-DENTAL PRODUCTS CO. 416 SOUTH TAYLOR AVE. Louisville, CO 80027 -3028 |
| Product Code | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-11-20 |
| Decision Date | 1996-03-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816519020305 | K955328 | 000 |
| 00816519020299 | K955328 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() CONFI-BOND 75027830 2058863 Live/Registered |
SEPTODONT, INC. 1995-11-15 |
![]() CONFI-BOND 74370005 not registered Dead/Abandoned |
CONFI-DENTAL PRODUCTS COMPANY 1993-03-22 |