Clearance Summary
NITE-GUIDE received FDA 510(k) clearance under submission number K931615, sponsored by ORTHO-TAIN, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1995-04-14.
- Submission: K931615
- Applicant / Sponsor: ORTHO-TAIN, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.5525
- Decision date: 1995-04-14
Classification & Regulation
This clearance is catalogued under FDA product code KMY and 21 CFR 872.5525, within the Dental review panel as a Class I device.