Aidite - Dental Scanner. - Amann Girrbach AG

Duns Number:300708950

Device Description: Dental Scanner.

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More Product Details

Catalog Number

179140-AID

Brand Name

Aidite

Version/Model Number

A-S1

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 25, 2020

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

cf6347ff-5faf-4a99-859d-0b0c6925086b

Public Version Date

February 21, 2022

Public Version Number

3

DI Record Publish Date

September 18, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"AMANN GIRRBACH AG" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 11
2 A medical device with a moderate to high risk that requires special controls. 1147
U Unclassified 6