Acrytemp CB A 3,5 - Dental Composite Material - ZHERMACK SPA

Duns Number:432971034

Device Description: Dental Composite Material

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More Product Details

Catalog Number

C700205

Brand Name

Acrytemp CB A 3,5

Version/Model Number

C700205

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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)

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

EBG

Product Code Name

CROWN AND BRIDGE, TEMPORARY, RESIN

Device Record Status

Public Device Record Key

79c5a3e5-73c9-44dc-93d7-a957c28077a4

Public Version Date

November 10, 2021

Public Version Number

4

DI Record Publish Date

September 09, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ZHERMACK SPA" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 9
2 A medical device with a moderate to high risk that requires special controls. 22