The following data is part of a premarket notification filed by W & H Dentalwerk Buermoos Gmbh with the FDA for Drilltech, Ism, Implantunit, Zimmer Surgical Motor System.
| Device ID | K060287 |
| 510k Number | K060287 |
| Device Name: | DRILLTECH, ISM, IMPLANTUNIT, ZIMMER SURGICAL MOTOR SYSTEM |
| Classification | Controller, Foot, Handpiece And Cord |
| Applicant | W & H DENTALWERK BUERMOOS GMBH IGNAZ GLASER STR. 53 Buermoos, AT A-5111 |
| Contact | Gabriele Wienbeck |
| Correspondent | Gabriele Wienbeck W & H DENTALWERK BUERMOOS GMBH IGNAZ GLASER STR. 53 Buermoos, AT A-5111 |
| Product Code | EBW |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-02-06 |
| Decision Date | 2006-05-03 |
| Summary: | summary |