Clearance Summary
OPTI-MAX PRESS-FIT EXTERNAL-HEX DENTAL received FDA 510(k) clearance under submission number K944943, sponsored by Opti-Max. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1995-03-13.
- Submission: K944943
- Applicant / Sponsor: Opti-Max
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3640
- Decision date: 1995-03-13
Classification & Regulation
This clearance is catalogued under FDA product code DZE and 21 CFR 872.3640, within the Dental review panel as a Class II device.