Clearance Summary
ATRISORB BIOABSORBABLE GUIDED TISSUE REGENERATION (GTR) BARRIER KIT received FDA 510(k) clearance under submission number K982865, sponsored by Atrix Laboratories, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1998-09-08.
- Submission: K982865
- Applicant / Sponsor: Atrix Laboratories, Inc.
- Clearance pathway: Special
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3930
- Decision date: 1998-09-08
Classification & Regulation
This clearance is catalogued under FDA product code NPK and 21 CFR 872.3930, within the Dental review panel as a Class II device.