Clearance Summary
STERNGOLD 66, MODEL #1180230 received FDA 510(k) clearance under submission number K021367, sponsored by Sterngold. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2002-05-16.
- Submission: K021367
- Applicant / Sponsor: Sterngold
- Clearance pathway: Abbreviated
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3060
- Decision date: 2002-05-16
Classification & Regulation
This clearance is catalogued under FDA product code EJS and 21 CFR 872.3060, within the Dental review panel as a Class II device.