K053103 is an FDA 510(k) clearance for the INTERFACE. This device is classified as a Agent, Tooth Bonding, Resin (Class II - Special Controls, product code KLE).
Submitted by Apex Dental Materials, Inc. (Deer Park, US). The FDA issued a Cleared decision on February 1, 2006, 89 days after receiving the submission on November 4, 2005.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3200.
| 510(k) Number | K053103 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 04, 2005 |
| Decision Date | February 01, 2006 |
| Days to Decision | 89 days |
| Submission Type | Abbreviated |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | KLE — Agent, Tooth Bonding, Resin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3200 |