K931329 is an FDA 510(k) clearance for the DENTAL INSTRUMENTS CURETTE PERIODONTAL. This device is classified as a Curette, Periodontic (Class I - General Controls, product code EMS).
Submitted by Minnesota Prophy Power, Inc. (Lakeville, US). The FDA issued a Cleared decision on January 27, 1994, 317 days after receiving the submission on March 16, 1993.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4565.
| 510(k) Number | K931329 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 16, 1993 |
| Decision Date | January 27, 1994 |
| Days to Decision | 317 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | EMS — Curette, Periodontic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.4565 |