Clearance Summary
DENTI-TRAY(TM) received FDA 510(k) clearance under submission number K871493, sponsored by Advanced Medical, 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 1987-06-24.
- Submission: K871493
- Applicant / Sponsor: Advanced Medical, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4565
- Decision date: 1987-06-24
Classification & Regulation
This clearance is catalogued under FDA product code EKW and 21 CFR 872.4565, within the Dental review panel as a Class I device.