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 |