Clearance Summary
LIQUID FILLED RING TEETHER, MODEL 03807, LIQUID FILLED RING TEETHER, MODELS 1962005, 1962011, LIQUID FILLED TEETHING received FDA 510(k) clearance under submission number K091198, sponsored by Allied Hill Enterprises, 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 2009-12-07.
- Submission: K091198
- Applicant / Sponsor: Allied Hill Enterprises, Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.5550
- Decision date: 2009-12-07
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.