System, Optical Impression, Computer Assisted Design and Manufacturing (Cad/Cam) of Dental Restorations

What Is It?

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.

What Is FDA Product Code NOF?

System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations is FDA product code NOF, Class 2, 21 CFR 872.3661.

What Does It Take to Sell It in the United States?

It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States.

What Has Gone Wrong With It?

The FDA has recorded 1 recall under this product code since 2021. None was by a company in China. The root cause the FDA records most often is Device Design (1).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.