K131043 is an FDA 510(k) clearance for the APEX UNIVERSAL ADHESIVE. This device is classified as a Agent, Tooth Bonding, Resin (Class II - Special Controls, product code KLE).
Submitted by Apex Dental Materials, Inc. (Lake Zurich, US). The FDA issued a Cleared decision on September 10, 2013, 148 days after receiving the submission on April 15, 2013.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3200.
| 510(k) Number | K131043 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 15, 2013 |
| Decision Date | September 10, 2013 |
| Days to Decision | 148 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 |