The following data is part of a premarket notification filed by W & H Dentalwerk Buermoos Gmbh with the FDA for W&h Handpiece Anesto, Model: Ra-5.
| Device ID | K083811 |
| 510k Number | K083811 |
| Device Name: | W&H HANDPIECE ANESTO, MODEL: RA-5 |
| Classification | Injector, Jet, Mechanical-powered |
| Applicant | W & H DENTALWERK BUERMOOS GMBH 53 IGNAZ-GLASER-STRASSE Buermoos, AT 5111 |
| Contact | Johann G Scharl |
| Correspondent | Johann G Scharl W & H DENTALWERK BUERMOOS GMBH 53 IGNAZ-GLASER-STRASSE Buermoos, AT 5111 |
| Product Code | EGM |
| CFR Regulation Number | 872.4475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-22 |
| Decision Date | 2010-01-14 |
| Summary: | summary |