K821364 is an FDA 510(k) clearance for the PROFLEX FLEXIBLE SCALER. This device is classified as a Strip, Polishing Agent (Class I - General Controls, product code EHM).
Submitted by Teledyne Densco (Mchenry, US). The FDA issued a Cleared decision on May 28, 1982, 21 days after receiving the submission on May 7, 1982.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6010.
| 510(k) Number | K821364 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 07, 1982 |
| Decision Date | May 28, 1982 |
| Days to Decision | 21 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
| Product Code | EHM — Strip, Polishing Agent |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.6010 |