Clearance Summary
PROFAST(R)-DENTURE CLEANSER received FDA 510(k) clearance under submission number K930337, 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 1993-09-07.
- Submission: K930337
- Applicant / Sponsor: Fittydent-Altwirth & Schmitt GmbH
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.3520
- Decision date: 1993-09-07
Classification & Regulation
This clearance is catalogued under FDA product code EFT and 21 CFR 872.3520, within the Dental review panel as a Class I device.