The following data is part of a premarket notification filed by Confi-dental Products Co. with the FDA for Caries Indicator.
| Device ID | K030807 |
| 510k Number | K030807 |
| Device Name: | CARIES INDICATOR |
| Classification | Device, Caries Detection |
| Applicant | CONFI-DENTAL PRODUCTS CO. 416 SOUTH TAYLOR AVE. Louisville, CO 80027 -3028 |
| Contact | Stephen Rudolph |
| Correspondent | Stephen Rudolph CONFI-DENTAL PRODUCTS CO. 416 SOUTH TAYLOR AVE. Louisville, CO 80027 -3028 |
| Product Code | LFC |
| CFR Regulation Number | 872.1740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-03-13 |
| Decision Date | 2003-06-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816519020596 | K030807 | 000 |
| 00816519020589 | K030807 | 000 |