The following data is part of a premarket notification filed by Fittydent-altwirth & Schmitt Gmbh with the FDA for Profast - Denture Adhesive For Lower Jaws.
| Device ID | K930335 |
| 510k Number | K930335 |
| Device Name: | PROFAST - DENTURE ADHESIVE FOR LOWER JAWS |
| Classification | Adhesive, Denture, Polyvinyl Methylether Maleic Acid Calcium-sodium Double Salt |
| 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 | KOO |
| CFR Regulation Number | 872.3490 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-01-22 |
| Decision Date | 1994-02-01 |