Clearance Summary
VITRO MOLAR received FDA 510(k) clearance under submission number K123826, 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 2013-02-14.
- Submission: K123826
- 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: 2013-02-14
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.