K240743 is an FDA 510(k) clearance for the Peak Universal Bond. This device is classified as a Agent, Tooth Bonding, Resin (Class II - Special Controls, product code KLE).
Submitted by Ultradent Products, Inc. (South Jordan, US). The FDA issued a Cleared decision on March 20, 2024, 2 days after receiving the submission on March 18, 2024.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3200.
| 510(k) Number | K240743 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 18, 2024 |
| Decision Date | March 20, 2024 |
| Days to Decision | 2 days |
| Submission Type | Special |
| 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 |