Clearance Summary
JAW FIXATION ASSEMBLY received FDA 510(k) clearance under submission number K863799, sponsored by Medical Products & Research, 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 1986-10-14.
- Submission: K863799
- Applicant / Sponsor: Medical Products & Research, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.4600
- Decision date: 1986-10-14
Classification & Regulation
This clearance is catalogued under FDA product code DYX and 21 CFR 872.4600, within the Dental review panel as a Class II device.