Clearance Summary
THE STERN ROOT ANCHOR SYSTEM received FDA 510(k) clearance under submission number K950213, 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 1995-03-23.
- Submission: K950213
- Applicant / Sponsor: Sterngold/Implamed
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.3810
- Decision date: 1995-03-23
Classification & Regulation
This clearance is catalogued under FDA product code ELR and 21 CFR 872.3810, within the Dental review panel as a Class I device.