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NOF — System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations Class II

FDA Device Classification

Classification Details

Product Code
NOF
Device Class
Class II
Regulation Number
872.3661
Submission Type
Review Panel
DE
Medical Specialty
Dental
Implant
No

Definition

An optical impression system for cad/cam of dental restorations is a device used to record the topographical characteristics of teeth, dental impressions, or stone models by analog or digital methods for use in the computer aided design and manufacturing of dental restorative prosthetic devices. Such systems may consist of a camera, scanner, or equivalent type of sensor and a computer with software.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K141611ormcoLYTHOS DIGITAL IMPRESSION SYSTEMDecember 5, 2014
K122065ormcoDIGITAL IMPRESSION SYSTEM FOR ORTHODONTIC USEFebruary 8, 2013
K1224673m3M TRUE DEFINITION SCANNERNovember 20, 2012
K081961brontes technologies3M UNITEK LAVA CHAIRSIDE ORAL SCANNERSeptember 5, 2008
K073199brontes technologies3M ESPE LAVA CHAIRSIDE ORAL SCANNERDecember 21, 2007