K133776 is an FDA 510(k) clearance for the A-DEC/W&H ELECTRIC HANDPIECE MOTOR. This device is classified as a Controller, Foot, Handpiece And Cord (Class I - General Controls, product code EBW).
Submitted by A-Dec, Inc. (Newberg, US). The FDA issued a Cleared decision on May 28, 2014, 167 days after receiving the submission on December 12, 2013.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4200.
| 510(k) Number | K133776 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 12, 2013 |
| Decision Date | May 28, 2014 |
| Days to Decision | 167 days |
| Submission Type | Special |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EBW — Controller, Foot, Handpiece And Cord |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.4200 |