K071158 is an FDA 510(k) clearance for the AURALAY PIT & FISSURE SEALANT. This device is classified as a Sealant, Pit And Fissure, And Conditioner (Class II - Special Controls, product code EBC).
Submitted by Denali Corporation (Hanover, US). The FDA issued a Cleared decision on June 5, 2007, 41 days after receiving the submission on April 25, 2007.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3765.
| 510(k) Number | K071158 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 25, 2007 |
| Decision Date | June 05, 2007 |
| Days to Decision | 41 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EBC — Sealant, Pit And Fissure, And Conditioner |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3765 |