Clearance Summary
XP Composite received FDA 510(k) clearance under submission number K182780, sponsored by S&C Polymer Silicon- Und Composite Spezialitaeten 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 2019-07-03.
- Submission: K182780
- Applicant / Sponsor: S&C Polymer Silicon- Und Composite Spezialitaeten GmbH
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3690
- Decision date: 2019-07-03
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.