Clearance Summary
PANASIL INITIAL CONTACT AND PANASIL TRAY received FDA 510(k) clearance under submission number K083701, sponsored by Kettenbach GmbH & Co. KG. The device was reviewed via the Special premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2009-01-09.
- Submission: K083701
- Applicant / Sponsor: Kettenbach GmbH & Co. KG
- Clearance pathway: Special
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3660
- Decision date: 2009-01-09
Classification & Regulation
This clearance is catalogued under FDA product code ELW and 21 CFR 872.3660, within the Dental review panel as a Class II device.