Clearance Summary
LC ResinCal PC received FDA 510(k) clearance under submission number K202413, 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 2020-11-20.
- Submission: K202413
- Applicant / Sponsor: S&C Polymer Silicon- Und Composite Spezialitaten GmbH
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3250
- Decision date: 2020-11-20
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.