The following data is part of a premarket notification filed by Young Dental Manufacturing Co 1, Llc. with the FDA for Paste, Pro Care Prophylaxis.
| Device ID | K782104 |
| 510k Number | K782104 |
| Device Name: | PASTE, PRO CARE PROPHYLAXIS |
| Classification | Prosthesis, Nose, Internal |
| Applicant | YOUNG DENTAL MANUFACTURING CO 1, LLC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | FZE |
| CFR Regulation Number | 878.3680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-12-19 |
| Decision Date | 1979-01-03 |