Clearance Summary
LC CALCIUMHYDROXIDE LINER received FDA 510(k) clearance under submission number K141047, sponsored by S&C Polymer Silicon- Und Composite Spezialitaeten. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2015-04-14.
- Submission: K141047
- Applicant / Sponsor: S&C Polymer Silicon- Und Composite Spezialitaeten
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3250
- Decision date: 2015-04-14
Classification & Regulation
This clearance is catalogued under FDA product code EJK and 21 CFR 872.3250, within the Dental review panel as a Class II device.