K152146 is an FDA 510(k) clearance for the High Speed Handpieces and Accessories. This device is classified as a Handpiece, Air-powered, Dental (Class I - General Controls, product code EFB).
Submitted by Codent Technical Industry Co., Ltd. (Kaohsiung City, TW). The FDA issued a Cleared decision on December 8, 2015, 127 days after receiving the submission on August 3, 2015.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4200.
| 510(k) Number | K152146 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 03, 2015 |
| Decision Date | December 08, 2015 |
| Days to Decision | 127 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 |