K821686 is an FDA 510(k) clearance for the DENSCO PROPHY ANGLE. This device is classified as a Handpiece, Contra- And Right-angle Attachment, Dental (Class I - General Controls, product code EGS).
Submitted by Teledyne Densco (Mchenry, US). The FDA issued a Cleared decision on June 25, 1982, 17 days after receiving the submission on June 8, 1982.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4200.
| 510(k) Number | K821686 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 08, 1982 |
| Decision Date | June 25, 1982 |
| Days to Decision | 17 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
| Product Code | EGS — Handpiece, Contra- And Right-angle Attachment, Dental |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.4200 |