Clearance Summary
OCCLUSAL HARMONY IMPRESSION TRAY received FDA 510(k) clearance under submission number K884316, sponsored by Advantage Dental Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1988-12-22.
- Submission: K884316
- Applicant / Sponsor: Advantage Dental Co.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6880
- Decision date: 1988-12-22
Classification & Regulation
This clearance is catalogued under FDA product code EHY and 21 CFR 872.6880, within the Dental review panel as a Class I device.