Clearance Summary
CRYSTALLESSENCE received FDA 510(k) clearance under submission number K954988, 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 1996-03-08.
- Submission: K954988
- Applicant / Sponsor: Confi-Dental Products Co.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3690
- Decision date: 1996-03-08
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.