K061322 is an FDA 510(k) clearance for the PORCELAIN PRIMER. This device is classified as a Agent, Tooth Bonding, Resin (Class II - Special Controls, product code KLE).
Submitted by J. Morita USA, Inc. (Irvine, US). The FDA issued a Cleared decision on June 2, 2006, 22 days after receiving the submission on May 11, 2006.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3200.
| 510(k) Number | K061322 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 11, 2006 |
| Decision Date | June 02, 2006 |
| Days to Decision | 22 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | KLE — Agent, Tooth Bonding, Resin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3200 |