K963927 is an FDA 510(k) clearance for the TEAM CARIES INDICATOR. This device is classified as a Device, Caries Detection (Class II - Special Controls, product code LFC).
Submitted by Centrix, Inc. (Shelton, US). The FDA issued a Cleared decision on November 15, 1996, 66 days after receiving the submission on September 10, 1996.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.1740.
| 510(k) Number | K963927 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 10, 1996 |
| Decision Date | November 15, 1996 |
| Days to Decision | 66 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | LFC — Device, Caries Detection |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.1740 |