Clearance Summary
INTERPORE IP 200 GRANULAR CORALLINE HYDROXYAPATITE BONE VOID FILLERS, 425 TO 1000 MICRONS AND 425 TO 600 MICRONS received FDA 510(k) clearance under submission number K950165, sponsored by Interpore Intl.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1995-03-28.
- Submission: K950165
- Applicant / Sponsor: Interpore Intl.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3930
- Decision date: 1995-03-28
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.