Clearance Summary
NAPA received FDA 510(k) clearance under submission number K902790, sponsored by G-Ortho Lab. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1990-09-19.
- Submission: K902790
- Applicant / Sponsor: G-Ortho Lab
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.5570
- Decision date: 1990-09-19
Classification & Regulation
This clearance is catalogued under FDA product code LQZ and 21 CFR 872.5570, within the Dental review panel as a Class II device.