The following data is part of a premarket notification filed by W&h Dentalwerk Burmoos Gmbh with the FDA for W&h Implantmed Si-1015 Incl. Accessories.
| Device ID | K161957 |
| 510k Number | K161957 |
| Device Name: | W&H Implantmed SI-1015 Incl. Accessories |
| Classification | Controller, Foot, Handpiece And Cord |
| Applicant | W&H DENTALWERK BURMOOS GMBH IGNAZ-GLASER-STRABE 53 Buermoos, AT 5111 |
| Contact | Anja Lindner |
| Correspondent | Anja Lindner W&H DENTALWERK BURMOOS GMBH IGNAZ-GLASER-STRABE 53 Buermoos, AT 5111 |
| Product Code | EBW |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-18 |
| Decision Date | 2016-11-23 |
| Summary: | summary |