The following data is part of a premarket notification filed by Ronvig Dental Mfg. A/s with the FDA for See-it Caries Detector.
| Device ID | K060330 |
| 510k Number | K060330 |
| Device Name: | SEE-IT CARIES DETECTOR |
| Classification | Device, Caries Detection |
| Applicant | RONVIG DENTAL MFG. A/S GL. VEJLEVEJ 59 Daugaard, DK Dk-8721 |
| Contact | Annette Ravn Nielsen |
| Correspondent | Annette Ravn Nielsen RONVIG DENTAL MFG. A/S GL. VEJLEVEJ 59 Daugaard, DK Dk-8721 |
| Product Code | LFC |
| CFR Regulation Number | 872.1740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-02-09 |
| Decision Date | 2006-04-07 |