Clearance Summary
Elos Accurate® Customized Abutment received FDA 510(k) clearance under submission number K190299, sponsored by Elos Medtech Pinol A/S. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2019-06-26.
- Submission: K190299
- Applicant / Sponsor: Elos Medtech Pinol A/S
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3630
- Decision date: 2019-06-26
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.