Clearance Summary
Visalys Tooth Primer received FDA 510(k) clearance under submission number K191524, 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 2019-09-29.
- Submission: K191524
- Applicant / Sponsor: Kettenbach GmbH & Co. KG
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3200
- Decision date: 2019-09-29
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.