Clearance Summary
EXCEL ULTRA-HI FORMULA HEAT-CURED DENTURE BASE MATERIAL received FDA 510(k) clearance under submission number K992176, sponsored by St. George Technology, 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 2000-02-10.
- Submission: K992176
- Applicant / Sponsor: St. George Technology, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3760
- Decision date: 2000-02-10
Classification & Regulation
This clearance is catalogued under FDA product code EBI and 21 CFR 872.3760, within the Dental review panel as a Class II device.