K022119 is an FDA 510(k) clearance for the EMS AIR-FLOW HANDY 2 DENTAL HANDPIECE. This device is classified as a Handpiece, Air-powered, Dental (Class I - General Controls, product code EFB).
Submitted by Electro Medical Systems SA (North Attleboro, US). The FDA issued a Cleared decision on July 25, 2002, 24 days after receiving the submission on July 1, 2002.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4200.
| 510(k) Number | K022119 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 01, 2002 |
| Decision Date | July 25, 2002 |
| Days to Decision | 24 days |
| Submission Type | Special |
| 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 |