The following data is part of a premarket notification filed by Durr Dental Ag with the FDA for Vistacam Ix Proof.
| Device ID | K150672 |
| 510k Number | K150672 |
| Device Name: | VistaCam IX Proof |
| Classification | Laser, Fluorescence Caries Detection |
| Applicant | Durr Dental AG Hopfigheimer Strasse 17 Bietigheim-bissingen, DE D-74321 |
| Contact | Oliver Lange |
| Correspondent | Pablo Martinez AIR TECHNIQUES, INC. 1295 WALT WHITMAN RD. Melville, NY 11747 |
| Product Code | NBL |
| CFR Regulation Number | 872.1745 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-16 |
| Decision Date | 2016-01-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E247J27101 | K150672 | 000 |
| E247J25101 | K150672 | 000 |
| E247J23101 | K150672 | 000 |
| E247J27121 | K150672 | 000 |