Clearance Summary
BIOFREE received FDA 510(k) clearance under submission number K033925, sponsored by Dental Components, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2004-04-07.
- Submission: K033925
- Applicant / Sponsor: Dental Components, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6640
- Decision date: 2004-04-07
Classification & Regulation
This clearance is catalogued under FDA product code EIA and 21 CFR 872.6640, within the Dental review panel as a Class I device.