Clearance Summary
BIO-GIDE RESORBABLE BILAYER MEMBRANE FOR GUIDED TISSUE AND BONE REGENERATION received FDA 510(k) clearance under submission number K042197, sponsored by Ed. Geistlich Soehne AG Fuer Chemische Industrie. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2004-11-15.
- Submission: K042197
- Applicant / Sponsor: Ed. Geistlich Soehne AG Fuer Chemische Industrie
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3930
- Decision date: 2004-11-15
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.