Clearance Summary
990 GOLD received FDA 510(k) clearance under submission number K894924, sponsored by Comprehensive Holistic Dentistry. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1989-10-30.
- Submission: K894924
- Applicant / Sponsor: Comprehensive Holistic Dentistry
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3060
- Decision date: 1989-10-30
Classification & Regulation
This clearance is catalogued under FDA product code EJT and 21 CFR 872.3060, within the Dental review panel as a Class II device.