Clearance Summary
PHOENIX OPTI-MAX DENT IMPL W/PLAS-SPRAY TITA/HYDRO received FDA 510(k) clearance under submission number K926101, sponsored by Phoenix Dental, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1994-06-23.
- Submission: K926101
- Applicant / Sponsor: Phoenix Dental, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3640
- Decision date: 1994-06-23
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.