K780752 is an FDA 510(k) clearance for the PROPHYLAXIS ANGLE. This device is classified as a Handpiece, Contra- And Right-angle Attachment, Dental (Class I - General Controls, product code EGS).
Submitted by Young Dental Manufacturing Co. 1, LLC (Mchenry, US). The FDA issued a Cleared decision on May 26, 1978, 18 days after receiving the submission on May 8, 1978.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4200.
| 510(k) Number | K780752 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 08, 1978 |
| Decision Date | May 26, 1978 |
| Days to Decision | 18 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 |