K782104 is an FDA 510(k) clearance for the PASTE, PRO CARE PROPHYLAXIS. This device is classified as a Prosthesis, Nose, Internal (Class II - Special Controls, product code FZE).
Submitted by Young Dental Manufacturing Co. 1, LLC (Walker, US). The FDA issued a Cleared decision on January 3, 1979, 15 days after receiving the submission on December 19, 1978.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.3680.
| 510(k) Number | K782104 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 19, 1978 |
| Decision Date | January 03, 1979 |
| Days to Decision | 15 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | - |
| Product Code | FZE - Prosthesis, Nose, Internal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.3680 |