Clearance Summary
GAMMA-BSM; BETA-BSM; EQUIVABONE received FDA 510(k) clearance under submission number K102812, sponsored by Etex Corporation. The device was reviewed via the Special premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2010-12-03.
- Submission: K102812
- Applicant / Sponsor: Etex Corporation
- Clearance pathway: Special
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3930
- Decision date: 2010-12-03
Classification & Regulation
This clearance is catalogued under FDA product code LYC and 21 CFR 872.3930, within the Dental review panel as a Class II device.