Clearance Summary
NEWGEN/UNIVERSAL MANDIBULAR SYSTEM received FDA 510(k) clearance under submission number K014263, sponsored by Stryker Instruments. The device was reviewed via the Special premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2002-03-08.
- Submission: K014263
- Applicant / Sponsor: Stryker Instruments
- Clearance pathway: Special
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.4760
- Decision date: 2002-03-08
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.