K012761 is an FDA 510(k) clearance for the PRIME-DENT VISIBLE LIGHT CURE PIT & FISSURE SEALANT. This device is classified as a Sealant, Pit And Fissure, And Conditioner (Class II - Special Controls, product code EBC).
Submitted by Prime Dental Manufacturing, Inc. (Chicago, US). The FDA issued a Cleared decision on November 1, 2001, 76 days after receiving the submission on August 17, 2001.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3765.
| 510(k) Number | K012761 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 17, 2001 |
| Decision Date | November 01, 2001 |
| Days to Decision | 76 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | EBC — Sealant, Pit And Fissure, And Conditioner |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3765 |