K010127 is an FDA 510(k) clearance for the W & H ASSISTINA. This device is classified as a Handpiece, Air-powered, Dental (Class I - General Controls, product code EFB).
Submitted by A-Dec, Inc. (Newberg, US). The FDA issued a Cleared decision on October 5, 2001, 275 days after receiving the submission on January 3, 2001.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4200.
| 510(k) Number | K010127 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 03, 2001 |
| Decision Date | October 05, 2001 |
| Days to Decision | 275 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | EFB — Handpiece, Air-powered, Dental |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.4200 |