Clearance Summary
Visalys Core, Visalys PL-Core, Visalys PL-Core-C, Visalys PL-Core-X received FDA 510(k) clearance under submission number K143104, sponsored by Kettenbach 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 2015-03-25.
- Submission: K143104
- Applicant / Sponsor: Kettenbach GmbH & Co. KG
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3690
- Decision date: 2015-03-25
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.