Clearance Summary
BII-PLAST received FDA 510(k) clearance under submission number K934947, sponsored by Bio-Interfaces, 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 1994-01-26.
- Submission: K934947
- Applicant / Sponsor: Bio-Interfaces, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3930
- Decision date: 1994-01-26
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.