K973200 is an FDA 510(k) clearance for the CARIES STAIN. This device is classified as a Device, Caries Detection (Class II - Special Controls, product code LFC).
Submitted by Parkell, Inc. (Farmingdale, US). The FDA issued a Cleared decision on November 6, 1997, 72 days after receiving the submission on August 26, 1997.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.1740.
| 510(k) Number | K973200 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 26, 1997 |
| Decision Date | November 06, 1997 |
| Days to Decision | 72 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | LFC — Device, Caries Detection |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.1740 |