Clearance Summary
Infinix Universal Composite, Infinix Flowable Composite, Infinix Bulk Fill Flow Composite received FDA 510(k) clearance under submission number K201010, sponsored by Nobio , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2020-08-14.
- Submission: K201010
- Applicant / Sponsor: Nobio , Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3690
- Decision date: 2020-08-14
Classification & Regulation
This clearance is catalogued under FDA product code EBF and 21 CFR 872.3690, within the Dental review panel as a Class II device.