The following data is part of a premarket notification filed by Duerr Dental Ag with the FDA for Camx Triton Hd Proxi Head.
| Device ID | K172007 |
| 510k Number | K172007 |
| Device Name: | CamX Triton HD Proxi Head |
| Classification | Caries Detector, Laser Light, Transmission |
| Applicant | Duerr Dental AG Hopfigheimer Strasse 17 Bietigheim-bissingen, DE D-74321 |
| Contact | Oliver Lange |
| Correspondent | Daniel Kamm Kamm & Associates 8870 Ravello Ct Naples, FL 34114 |
| Product Code | NTK |
| CFR Regulation Number | 872.1745 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-07-03 |
| Decision Date | 2017-11-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E247J29101 | K172007 | 000 |
| E247J29001 | K172007 | 000 |
| E247J27001 | K172007 | 000 |
| E247J26001 | K172007 | 000 |
| E247J25001 | K172007 | 000 |
| E247J27131 | K172007 | 000 |