Clearance Summary
SIMPLELINE II MODEL SOFX483408R, SOFX483410R TOTAL 44 MODELS received FDA 510(k) clearance under submission number K102308, sponsored by Dentium Co., Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2010-11-22.
- Submission: K102308
- Applicant / Sponsor: Dentium Co., Ltd.
- Clearance pathway: Special
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3640
- Decision date: 2010-11-22
Classification & Regulation
This clearance is catalogued under FDA product code DZE and 21 CFR 872.3640, within the Dental review panel as a Class II device.