Clearance Summary
PERMAGEN UNIVERSAL BONDING RESIN received FDA 510(k) clearance under submission number K933745, sponsored by Bio-Systems Research. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1994-01-26.
- Submission: K933745
- Applicant / Sponsor: Bio-Systems Research
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.3670
- Decision date: 1994-01-26
Classification & Regulation
This clearance is catalogued under FDA product code EBH and 21 CFR 872.3670, within the Dental review panel as a Class I device.