Clearance Summary
BIO-C Sealer Ion+ received FDA 510(k) clearance under submission number K190537, sponsored by Angelus Industria DE Produtos Odontologicos S/A. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2019-12-12.
- Submission: K190537
- Applicant / Sponsor: Angelus Industria DE Produtos Odontologicos S/A
- Clearance pathway: Abbreviated
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3820
- Decision date: 2019-12-12
Classification & Regulation
This clearance is catalogued under FDA product code KIF and 21 CFR 872.3820, within the Dental review panel as a Class II device.