Clearance Summary
COMPUTED DENTAL RADIOGRAPHY received FDA 510(k) clearance under submission number K110768, sponsored by Schick Technologies, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2011-04-20.
- Submission: K110768
- Applicant / Sponsor: Schick Technologies, Inc.
- Clearance pathway: Special
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.1800
- Decision date: 2011-04-20
Classification & Regulation
This clearance is catalogued under FDA product code MUH and 21 CFR 872.1800, within the Dental review panel as a Class II device.