K113301 is an FDA 510(k) clearance for the CONCENPIECE,HIGH-SPEED HANDPIECE SERIES. This device is classified as a Handpiece, Air-powered, Dental (Class I - General Controls, product code EFB).
Submitted by Dentalez, Inc. (Lancaster, US). The FDA issued a Cleared decision on January 23, 2012, 76 days after receiving the submission on November 8, 2011.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4200.
| 510(k) Number | K113301 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 08, 2011 |
| Decision Date | January 23, 2012 |
| Days to Decision | 76 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EFB - Handpiece, Air-powered, Dental |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.4200 |