Clearance Summary
REGENEROSS ALLOGRAFT PLUS MINERLIZED received FDA 510(k) clearance under submission number K113645, sponsored by Biomet Interpore Cross. The device was reviewed via the Special premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2012-01-20.
- Submission: K113645
- Applicant / Sponsor: Biomet Interpore Cross
- Clearance pathway: Special
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3930
- Decision date: 2012-01-20
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.