K171226 is an FDA 510(k) clearance for the TOKUYAMA UNIVERSAL BOND. This device is classified as a Agent, Tooth Bonding, Resin (Class II - Special Controls, product code KLE).
Submitted by Tokuyama Dental Corporation (Tokyo, JP). The FDA issued a Cleared decision on November 28, 2017, 216 days after receiving the submission on April 26, 2017.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3200.
| 510(k) Number | K171226 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 26, 2017 |
| Decision Date | November 28, 2017 |
| Days to Decision | 216 days |
| Submission Type | Traditional |
| 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 |