Clearance Summary
BI-PHASE SET, ORAL, MAXILLOFACIAL SURGERY received FDA 510(k) clearance under submission number K901095, sponsored by Grimm & Norton. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1990-04-27.
- Submission: K901095
- Applicant / Sponsor: Grimm & Norton
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.4760
- Decision date: 1990-04-27
Classification & Regulation
This clearance is catalogued under FDA product code JEY and 21 CFR 872.4760, within the Dental review panel as a Class II device.