Clearance Summary
OSTEOGEN SBRG received FDA 510(k) clearance under submission number K033098, sponsored by Impladent , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2004-04-27.
- Submission: K033098
- Applicant / Sponsor: Impladent , Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3930
- Decision date: 2004-04-27
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.