K780199 is an FDA 510(k) clearance for the PROPHY ANGLES, R&R. This device is classified as a Handpiece, Contra- And Right-angle Attachment, Dental (Class I - General Controls, product code EGS).
Submitted by Ransom and Randolph (Mchenry, US). The FDA issued a Cleared decision on February 16, 1978, 9 days after receiving the submission on February 7, 1978.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4200.
| 510(k) Number | K780199 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 07, 1978 |
| Decision Date | February 16, 1978 |
| Days to Decision | 9 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 |