Clearance Summary
STERNIC IMPLANT 4.2MM RN, 1.8MM, 8.0MM / 4.1MM RN, 1.8MM, 10.MM / 4.1 MM RN, 1.8MM, 12.0MM / 4.1MM RN, 1.8MM, 14.0MM ... received FDA 510(k) clearance under submission number K111798, sponsored by Sterngold Dental, LLC. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2012-06-01.
- Submission: K111798
- Applicant / Sponsor: Sterngold Dental, LLC
- Clearance pathway: Abbreviated
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3640
- Decision date: 2012-06-01
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.