Clearance Summary
COMPOSITE RESTORATIVE MATERIAL/RADIOPAQUE received FDA 510(k) clearance under submission number K904812, sponsored by Alpha-Dent. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1991-02-26.
- Submission: K904812
- Applicant / Sponsor: Alpha-Dent
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3690
- Decision date: 1991-02-26
Classification & Regulation
This clearance is catalogued under FDA product code EBF and 21 CFR 872.3690, within the Dental review panel as a Class II device.