K213965 is an FDA 510(k) clearance for the BeautiBond Xtreme. This device is classified as a Agent, Tooth Bonding, Resin (Class II - Special Controls, product code KLE).
Submitted by Shofu Dental Corporation (San Marcos, US). The FDA issued a Cleared decision on March 18, 2022, 88 days after receiving the submission on December 20, 2021.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3200.
| 510(k) Number | K213965 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 20, 2021 |
| Decision Date | March 18, 2022 |
| Days to Decision | 88 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 |