Clearance Summary
LC ChromeFlow received FDA 510(k) clearance under submission number K222445, sponsored by S&C Polymer Silicon- Und Composite Spezialitaten GmbH. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2023-03-06.
- Submission: K222445
- Applicant / Sponsor: S&C Polymer Silicon- Und Composite Spezialitaten GmbH
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3690
- Decision date: 2023-03-06
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.