The following data is part of a premarket notification filed by Noxell with the FDA for Plaque-x Denture Cleanser.
| Device ID | K791716 |
| 510k Number | K791716 |
| Device Name: | PLAQUE-X DENTURE CLEANSER |
| Classification | Cleaner, Denture, Mechanical |
| Applicant | NOXELL 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JER |
| CFR Regulation Number | 872.3530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-08-31 |
| Decision Date | 1979-10-23 |