K180803 is an FDA 510(k) clearance for the BeautiBond Universal. 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 September 26, 2018, 182 days after receiving the submission on March 28, 2018.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3200.
| 510(k) Number | K180803 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 28, 2018 |
| Decision Date | September 26, 2018 |
| Days to Decision | 182 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 |