Clearance Summary
LuxaCrown, Shade A1, A2, A3, A3.5; LuxaCrown B1, B3, C2, D2 received FDA 510(k) clearance under submission number K183337, sponsored by DMG Chemisch-Pharmazeutische Fabrik 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 2019-05-29.
- Submission: K183337
- Applicant / Sponsor: DMG Chemisch-Pharmazeutische Fabrik GmbH
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3770
- Decision date: 2019-05-29
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.