Clearance Summary
PROFAST - DENTURE ADHESIVE FOR LOWER JAWS received FDA 510(k) clearance under submission number K930335, sponsored by Fittydent-Altwirth & Schmitt GmbH. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1994-02-01.
- Submission: K930335
- Applicant / Sponsor: Fittydent-Altwirth & Schmitt GmbH
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.3490
- Decision date: 1994-02-01
Classification & Regulation
This clearance is catalogued under FDA product code KOO and 21 CFR 872.3490, within the Dental review panel as a Class I device.