K240337 is an FDA 510(k) clearance for the Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L). This device is classified as a Handpiece, Air-powered, Dental (Class I - General Controls, product code EFB).
Submitted by Guangdong Jinme Medical Technology Co., Ltd. (Foshan, CN). The FDA issued a Cleared decision on November 13, 2024, 282 days after receiving the submission on February 5, 2024.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4200.
| 510(k) Number | K240337 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 05, 2024 |
| Decision Date | November 13, 2024 |
| Days to Decision | 282 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 |