The following data is part of a premarket notification filed by Cariescan Ltd. with the FDA for Cariescan Pro.
| Device ID | K090598 |
| 510k Number | K090598 |
| Device Name: | CARIESCAN PRO |
| Classification | Laser, Fluorescence Caries Detection |
| Applicant | CARIESCAN LTD. PROSPECT BUSINESS CENTRE THE TECHNOLOGY PARK Dundee, GB Dd2 1sw |
| Contact | Nikola Skelly |
| Correspondent | Nikola Skelly CARIESCAN LTD. PROSPECT BUSINESS CENTRE THE TECHNOLOGY PARK Dundee, GB Dd2 1sw |
| Product Code | NBL |
| CFR Regulation Number | 872.1745 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-03-05 |
| Decision Date | 2009-12-15 |
| Summary: | summary |