Clearance Summary
VITRO FIL LC received FDA 510(k) clearance under submission number K123824, sponsored by Dfl Industria E Comercio SA. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2013-02-21.
- Submission: K123824
- Applicant / Sponsor: Dfl Industria E Comercio SA
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3275
- Decision date: 2013-02-21
Classification & Regulation
This clearance is catalogued under FDA product code EMA and 21 CFR 872.3275, within the Dental review panel as a Class II device.