Clearance Summary
THE STERN ERA SYSTEM received FDA 510(k) clearance under submission number K913348, sponsored by Sterngold/Implamed. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1992-01-30.
- Submission: K913348
- Applicant / Sponsor: Sterngold/Implamed
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3640
- Decision date: 1992-01-30
Classification & Regulation
This clearance is catalogued under FDA product code DZE and 21 CFR 872.3640, within the Dental review panel as a Class II device.