Clearance Summary
REGENAFIL, REGENAFORM, ALRIVA DBM PASTE, SLTIVA DM WITH CORTICAL CANCELLOUS SHIPS, BIOSET, SIOSET IC, RTI ALLOGRAFT PAST received FDA 510(k) clearance under submission number K080418, sponsored by Regeneration Technologies, 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 2008-04-30.
- Submission: K080418
- Applicant / Sponsor: Regeneration Technologies, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3930
- Decision date: 2008-04-30
Classification & Regulation
This clearance is catalogued under FDA product code NUN and 21 CFR 872.3930, within the Dental review panel as a Class II device.