K131734 is an FDA 510(k) clearance for the ALL-BOND UNIVERSAL SC (NOT FINALIZED). This device is classified as a Agent, Tooth Bonding, Resin (Class II - Special Controls, product code KLE).
Submitted by Bisco, Inc. (Schaumburg, US). The FDA issued a Cleared decision on April 11, 2014, 302 days after receiving the submission on June 13, 2013.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3200.
| 510(k) Number | K131734 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 13, 2013 |
| Decision Date | April 11, 2014 |
| Days to Decision | 302 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 |