The following data is part of a premarket notification filed by W & H Dentalwerk Buermoos Gmbh with the FDA for Prosthodontic Screwdriver , Model Ia-400.
| Device ID | K100600 |
| 510k Number | K100600 |
| Device Name: | PROSTHODONTIC SCREWDRIVER , MODEL IA-400 |
| Classification | Handpiece, Direct Drive, Ac-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 | EKX |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-03-03 |
| Decision Date | 2010-07-09 |
| Summary: | summary |