The following data is part of a premarket notification filed by Kaltenbach & Voigt Gmbh with the FDA for Dexis Carivu 3-in-1 By Kavo.
| Device ID | K182712 |
| 510k Number | K182712 |
| Device Name: | DEXIS CariVu 3-in-1 By KaVo |
| Classification | Caries Detector, Laser Light, Transmission |
| Applicant | Kaltenbach & Voigt GmbH Bismarckring 39 Biberach, DE 88440 |
| Contact | Stefan Trampler |
| Correspondent | Frank Ray KaVo Dental Technologies, LLC 11727 Fruehauf Drive Charlotte, NC 28273 |
| Product Code | NTK |
| CFR Regulation Number | 872.1745 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-27 |
| Decision Date | 2019-11-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EKAV101317000 | K182712 | 000 |
| EKAV101144440 | K182712 | 000 |