Clearance Summary
CRYSTALLINE 'FLUORITE' CORE BUILD-UP MATERIAL received FDA 510(k) clearance under submission number K933199, sponsored by Confi-Dental Products Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1994-01-06.
- Submission: K933199
- Applicant / Sponsor: Confi-Dental Products Co.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3275
- Decision date: 1994-01-06
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.