The following data is part of a premarket notification filed by Kaltenbach & Voigt Gmbh & Co. with the FDA for Comfortronic 4894 And Comfortdrive 200xda Handpiece.
| Device ID | K080677 |
| 510k Number | K080677 |
| Device Name: | COMFORTRONIC 4894 AND COMFORTDRIVE 200XDA HANDPIECE |
| Classification | Unit, Operative Dental |
| Applicant | KALTENBACH & VOIGT GMBH & CO. 1717 WEST COLLINS Orange, CA 92867 |
| Contact | Claudia Ortiz |
| Correspondent | Claudia Ortiz KALTENBACH & VOIGT GMBH & CO. 1717 WEST COLLINS Orange, CA 92867 |
| Product Code | EIA |
| CFR Regulation Number | 872.6640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-10 |
| Decision Date | 2008-06-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EKAV100736560 | K080677 | 000 |
| EKAV100735700 | K080677 | 000 |
| EKAV100501690 | K080677 | 000 |