The following data is part of a premarket notification filed by W & H Dentalwerk Buermoos Gmbh with the FDA for Implantmed Si-95 115 (100-130 V) And Si-95 230 (220-240 V).
| Device ID | K002469 |
| 510k Number | K002469 |
| Device Name: | IMPLANTMED SI-95 115 (100-130 V) AND SI-95 230 (220-240 V) |
| Classification | Controller, Foot, Handpiece And Cord |
| Applicant | W & H DENTALWERK BUERMOOS GMBH IGNAZ GLASER STR. 53 Buermoos, AT A-5111 |
| Contact | Herbert Traschwandtner |
| Correspondent | Herbert Traschwandtner 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 | 2000-08-11 |
| Decision Date | 2001-02-07 |