K972642 is an FDA 510(k) clearance for the PERIO CONTROL II. This device is classified as a Carver, Wax, Dental (Class I - General Controls, product code EIK).
Submitted by Estrad B.V. (Deer Field, US). The FDA issued a Cleared decision on January 26, 1998, 195 days after receiving the submission on July 15, 1997.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4565.
| 510(k) Number | K972642 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 15, 1997 |
| Decision Date | January 26, 1998 |
| Days to Decision | 195 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EIK — Carver, Wax, Dental |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.4565 |