Clearance Summary
Infinity Pro, Logic, Quality, Sprint received FDA 510(k) clearance under submission number K213742, sponsored by Olsen Indústria E Comércio S.A.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2022-10-19.
- Submission: K213742
- Applicant / Sponsor: Olsen Indústria E Comércio S.A.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6640
- Decision date: 2022-10-19
Classification & Regulation
This clearance is catalogued under FDA product code EIA and 21 CFR 872.6640, within the Dental review panel as a Class I device.