Clearance Summary
DENTAL ARCH BAR received FDA 510(k) clearance under submission number K820944, sponsored by Unisplint Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1982-05-05.
- Submission: K820944
- Applicant / Sponsor: Unisplint Corp.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.4600
- Decision date: 1982-05-05
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.