The following data is part of a premarket notification filed by Confi-dental Products Co. with the FDA for Baritone C2 & Baritone L3.
| Device ID | K914322 |
| 510k Number | K914322 |
| Device Name: | BARITONE C2 & BARITONE L3 |
| Classification | Sealant, Pit And Fissure, And Conditioner |
| Applicant | CONFI-DENTAL PRODUCTS CO. 385 S. PIERCE AVE. COLORADO TECH CENTER Louisville, CO 80027 -3017 |
| Contact | Sharon A Lutton |
| Correspondent | Sharon A Lutton CONFI-DENTAL PRODUCTS CO. 385 S. PIERCE AVE. COLORADO TECH CENTER Louisville, CO 80027 -3017 |
| Product Code | EBC |
| CFR Regulation Number | 872.3765 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-09-26 |
| Decision Date | 1991-10-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816519020695 | K914322 | 000 |
| 00816519020664 | K914322 | 000 |