Clearance Summary
COPRA TEMP PMMA-DISK received FDA 510(k) clearance under submission number K131664, sponsored by White Peaks Dental Systems GmbH & Co. KG. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2013-12-18.
- Submission: K131664
- Applicant / Sponsor: White Peaks Dental Systems GmbH & Co. KG
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3770
- Decision date: 2013-12-18
Classification & Regulation
This clearance is catalogued under FDA product code EBG and 21 CFR 872.3770, within the Dental review panel as a Class II device.