Clearance Summary
UniPrime A, UniPrime E, UniPrime E/C received FDA 510(k) clearance under submission number K221033, sponsored by S&C Polymer Silicon- Und Composite Spezialitäten 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 2022-07-06.
- Submission: K221033
- Applicant / Sponsor: S&C Polymer Silicon- Und Composite Spezialitäten GmbH
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3200
- Decision date: 2022-07-06
Classification & Regulation
This clearance is catalogued under FDA product code KLE and 21 CFR 872.3200, within the Dental review panel as a Class II device.