The following data is part of a premarket notification filed by W & H Dentalwerk Buermoos Gmbh with the FDA for Implantmed Si-915 (115v Version); Implantmed Si-923 (230v Version) Incl. Accessories.
| Device ID | K052741 |
| 510k Number | K052741 |
| Device Name: | IMPLANTMED SI-915 (115V VERSION); IMPLANTMED SI-923 (230V VERSION) INCL. ACCESSORIES |
| 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 | 2005-09-30 |
| Decision Date | 2006-01-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00883205101648 | K052741 | 000 |