Clearance Summary
GUMEASE DENTAL MOUTHPIECE received FDA 510(k) clearance under submission number K072082, sponsored by Biomedevice , 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 2007-11-05.
- Submission: K072082
- Applicant / Sponsor: Biomedevice , Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.5550
- Decision date: 2007-11-05
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.