Nobel Procera - Nobel Procera 2G - Dental Scanner - OPTIMET

Duns Number:531984441

Device Description: Nobel Procera 2G - Dental Scanner

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More Product Details

Catalog Number

-

Brand Name

Nobel Procera

Version/Model Number

2G

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 29, 2018

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)

-

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

53270e0c-1792-46b0-80f7-e8595ce6e8d5

Public Version Date

February 21, 2022

Public Version Number

4

DI Record Publish Date

November 21, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"OPTIMET" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 4