ChairsideCAD - ChairsideCAD is a software device intended to - exocad GmbH

Duns Number:341575872

Device Description: ChairsideCAD is a software device intended to support the design of dental restorations su ChairsideCAD is a software device intended to support the design of dental restorations such as inlays, onlays, crowns, copings,veneers, bridges, pontics, provisionals, and bite splints via a 3D CAD tool. The design is basedon suitable 3D scans of the patient’s dental anatomy produced by a compatible scanner. The software generates geometricaloutput of the design for manufacturing on compatible CAM systems.ChairsideCAD is intended to be used by trained professionals in dental practices and is not to be used for any purpose otherthan the design of dental restorations or bite splints, nor is it to be used for designing dental abutments.

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

ChairsideCAD

Version/Model Number

2.1

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

February 19, 2023

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

NOF

Product Code Name

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

Device Record Status

Public Device Record Key

f646607e-8412-4daa-8f44-cea40ec35c42

Public Version Date

February 21, 2022

Public Version Number

4

DI Record Publish Date

February 20, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"EXOCAD GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 5
2 A medical device with a moderate to high risk that requires special controls. 8