Clearance Summary
Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed, Geistlich Bio-Gide Perio, Geistlich Combi-Kit Collagen, Geistlich Perio-System Combi-Pack, Geistlich Mucograft and Geistlich Mucograft Seal received FDA 510(k) clearance under submission number K192042, sponsored by Geistlich Pharma AG. The device was reviewed via the Special premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2019-08-29.
- Submission: K192042
- Applicant / Sponsor: Geistlich Pharma AG
- Clearance pathway: Special
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3930
- Decision date: 2019-08-29
Classification & Regulation
This clearance is catalogued under FDA product code NPL and 21 CFR 872.3930, within the Dental review panel as a Class II device.