DeviceClearance

Product code NOF— Dental

3M ESPE LAVA CHAIRSIDE ORAL SCANNER

Classification name
System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations
Device class
Class 2
Regulation
21 CFR 872.3661
Advisory panel
Dental
Total cleared
5
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code NOF under 21 CFR 872.3661, via openFDA

Market context for product code NOF

FDA has cleared 5 devices under product code NOF between 2007 and 2014, filed by 3 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code NOF

Recent clearances under product code NOF

Data sourced from openFDA. This site is unofficial and independent of the FDA.