The following data is part of a premarket notification filed by Pennex Products Co., Inc. with the FDA for Denture Cleansing Tablet.
| Device ID | K871785 |
| 510k Number | K871785 |
| Device Name: | DENTURE CLEANSING TABLET |
| Classification | Cleanser, Denture, Over The Counter |
| Applicant | PENNEX PRODUCTS CO., INC. EASTERN AVE. AT PENNEX DR. Verona, PA 15147 |
| Contact | Hal Mendlowitz |
| Correspondent | Hal Mendlowitz PENNEX PRODUCTS CO., INC. EASTERN AVE. AT PENNEX DR. Verona, PA 15147 |
| Product Code | EFT |
| CFR Regulation Number | 872.3520 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-05-06 |
| Decision Date | 1987-09-11 |