Clearance Summary
FLUID-FILLED TEETHER received FDA 510(k) clearance under submission number K083512, sponsored by Wiltec Industries , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2009-04-22.
- Submission: K083512
- Applicant / Sponsor: Wiltec Industries , Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.5550
- Decision date: 2009-04-22
Classification & Regulation
This clearance is catalogued under FDA product code KKO and 21 CFR 872.5550, within the Dental review panel as a Class II device.