Clearance Summary
STERNOMEGA TEMPORARY CEMENT AUTOMIX NE, MODEL 220282/220281 received FDA 510(k) clearance under submission number K984340, sponsored by Sterngold/Implamed. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1999-01-08.
- Submission: K984340
- Applicant / Sponsor: Sterngold/Implamed
- Clearance pathway: Abbreviated
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3275
- Decision date: 1999-01-08
Classification & Regulation
This clearance is catalogued under FDA product code EMA and 21 CFR 872.3275, within the Dental review panel as a Class II device.