Clearance Summary
PHOT-X II, MODEL 303 received FDA 510(k) clearance under submission number K042260, sponsored by Takara Belmont USA, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2004-09-07.
- Submission: K042260
- Applicant / Sponsor: Takara Belmont USA, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.1800
- Decision date: 2004-09-07
Classification & Regulation
This clearance is catalogued under FDA product code EHD and 21 CFR 872.1800, within the Dental review panel as a Class II device.