Clearance Summary
BIO-2000 received FDA 510(k) clearance under submission number K973765, sponsored by Micrylium Laboratories. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1998-11-04.
- Submission: K973765
- Applicant / Sponsor: Micrylium Laboratories
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6640
- Decision date: 1998-11-04
Classification & Regulation
This clearance is catalogued under FDA product code EIA and 21 CFR 872.6640, within the Dental review panel as a Class I device.