Clearance Summary
visio.lign color, visio.lign shield received FDA 510(k) clearance under submission number K240735, sponsored by Bredent 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 2024-12-12.
- Submission: K240735
- Applicant / Sponsor: Bredent GmbH & Co. KG
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3310
- Decision date: 2024-12-12
Classification & Regulation
This clearance is catalogued under FDA product code EBD and 21 CFR 872.3310, within the Dental review panel as a Class II device.