Delta Zirconia Multilayered Translucent - 98X18mm Multilayered Translucent Shade C2 - AURIDENT INC

Duns Number:030580955

Device Description: 98X18mm Multilayered Translucent Shade C2

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More Product Details

Catalog Number

-

Brand Name

Delta Zirconia Multilayered Translucent

Version/Model Number

D820C2MUL/T

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

Yes

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

EIH

Product Code Name

Powder, Porcelain

Device Record Status

Public Device Record Key

e0440c13-2221-480d-be20-30128b86e28f

Public Version Date

November 04, 2019

Public Version Number

4

DI Record Publish Date

October 20, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"AURIDENT INC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 519