Clearance Summary
ERA MICRO 23 FEMALE ABUTMENT, ERA MICRO 30 FEMALE ABUTMENT received FDA 510(k) clearance under submission number K130408, 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 2013-07-01.
- Submission: K130408
- Applicant / Sponsor: Sterngold Dental, LLC
- Clearance pathway: Abbreviated
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3630
- Decision date: 2013-07-01
Classification & Regulation
This clearance is catalogued under FDA product code NHA and 21 CFR 872.3630, within the Dental review panel as a Class II device.