NOFClass II

System, Optical Impression, Computer Assisted Design And Manufacturing (cad/cam) Of Dental Restorations

Dental · 21 CFR 872.3661

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.

MDR events36All time

Recalls1All time

Registered firms157Currently listed

510(k) clearances5All time

Recent MDR events

36 adverse event reports on file

Event type breakdown

Malfunction15

Injury14

Other5

Unspecified2

Most-reported manufacturers

3m Espe Dental Products22 Align Technology, Ltd.6 Carestream Dental Llc2 D4d Technologies, Llc2 Unspecified1 Ivoclar Vivadent Ag1 Unk1 Unknown1

Recalls

1 recall events for this product code

CARESTREAM DENTAL, LLC
TerminatedUnknown
Carestream Dental CS 3600 Single Use Normal Tips, Catalog Number 5941216 - Product Usage: used to record the topographic characteristics of teeth or dental impr
The mirror may become detached and fall from the unit
Z-1268-2021 · View FDA record ↗

Registered firms

157 firms currently registered for this product code

510(k) clearances

5 clearances for this product code