Clearance Summary
BI-CENTRIC SYSTEM received FDA 510(k) clearance under submission number K760404, sponsored by Pelton & Crane Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1976-08-23.
- Submission: K760404
- Applicant / Sponsor: Pelton & Crane Co.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6250
- Decision date: 1976-08-23
Classification & Regulation
This clearance is catalogued under FDA product code KLC and 21 CFR 872.6250, within the Dental review panel as a Class I device.