Clearance Summary
NAVI ROOT received FDA 510(k) clearance under submission number K083901, sponsored by S-Denti Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Unknown review panel. The statutory decision date of record is 2009-04-15.
- Submission: K083901
- Applicant / Sponsor: S-Denti Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Unknown
- Device class:
- Decision date: 2009-04-15
Classification & Regulation
This clearance is catalogued under FDA product code LQY , within the Unknown review panel as a device.