Clearance Summary
NEWGEN SYSTEM received FDA 510(k) clearance under submission number K002619, sponsored by Stryker Instruments. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2000-11-16.
- Submission: K002619
- Applicant / Sponsor: Stryker Instruments
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.4760
- Decision date: 2000-11-16
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.