Clearance Summary
CROWN INDEX TRAY received FDA 510(k) clearance under submission number K842273, sponsored by Di-Equi Dental Products. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1984-07-31.
- Submission: K842273
- Applicant / Sponsor: Di-Equi Dental Products
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6880
- Decision date: 1984-07-31
Classification & Regulation
This clearance is catalogued under FDA product code EHY and 21 CFR 872.6880, within the Dental review panel as a Class I device.