K083811 is an FDA 510(k) clearance for the W&H HANDPIECE ANESTO, MODEL: RA-5. This device is classified as a Injector, Jet, Mechanical-powered (Class II - Special Controls, product code EGM).
Submitted by W&H Dentalwerk Buermoos GmbH (Buermoos, AT). The FDA issued a Cleared decision on January 14, 2010, 388 days after receiving the submission on December 22, 2008.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4475.
| 510(k) Number | K083811 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 22, 2008 |
| Decision Date | January 14, 2010 |
| Days to Decision | 388 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EGM - Injector, Jet, Mechanical-powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.4475 |