3shape scanner - 3shape scanner - WHIP-MIX CORPORATION

Duns Number:006385173

Device Description: 3shape scanner

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More Product Details

Catalog Number

-

Brand Name

3shape scanner

Version/Model Number

709531

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 29, 2022

Issuing Agency

In HIBCC

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)

-

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

82c23aea-9766-47fb-baf9-84f5de53eb88

Public Version Date

September 30, 2022

Public Version Number

3

DI Record Publish Date

September 22, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"WHIP-MIX CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 63
2 A medical device with a moderate to high risk that requires special controls. 293
U Unclassified 1