The following data is part of a premarket notification filed by Fittydent-altwirth & Schmitt Gmbh with the FDA for Profast(r)-denture Cleanser.
| Device ID | K930337 |
| 510k Number | K930337 |
| Device Name: | PROFAST(R)-DENTURE CLEANSER |
| Classification | Cleanser, Denture, Over The Counter |
| Applicant | FITTYDENT-ALTWIRTH & SCHMITT GMBH 333 WEST WACLER DR. SIOTE 2600 Chicago, IL 60606 |
| Contact | Thomas J Muldoon |
| Correspondent | Thomas J Muldoon FITTYDENT-ALTWIRTH & SCHMITT GMBH 333 WEST WACLER DR. SIOTE 2600 Chicago, IL 60606 |
| Product Code | EFT |
| CFR Regulation Number | 872.3520 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-01-22 |
| Decision Date | 1993-09-07 |