The following data is part of a premarket notification filed by W & H Dentalwerk Buermoos Gmbh with the FDA for Contra-angle Handpiece Komet Os30.
| Device ID | K090548 |
| 510k Number | K090548 |
| Device Name: | CONTRA-ANGLE HANDPIECE KOMET OS30 |
| Classification | Handpiece, Air-powered, Dental |
| Applicant | W & H DENTALWERK BUERMOOS GMBH IGNAZ GLASER STR. 53 Buermoos, AT A-5111 |
| Contact | Johann Georg Scharl |
| Correspondent | Johann Georg Scharl W & H DENTALWERK BUERMOOS GMBH IGNAZ GLASER STR. 53 Buermoos, AT A-5111 |
| Product Code | EFB |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-03-02 |
| Decision Date | 2009-06-30 |
| Summary: | summary |