Clearance Summary
MBS HARD TISSUE REPLACEMENT SYSTEM received FDA 510(k) clearance under submission number K832509, sponsored by Medical Biological Sciences, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1983-11-29.
- Submission: K832509
- Applicant / Sponsor: Medical Biological Sciences, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3930
- Decision date: 1983-11-29
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.