crea.lign paste Dentin A3 - crea.lign paste Dentin A3 Light curing composite - bredent GmbH & Co. KG

Duns Number:341086190

Device Description: crea.lign paste Dentin A3 Light curing composite nanofilled 3 g

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More Product Details

Catalog Number

CLPNDA30

Brand Name

crea.lign paste Dentin A3

Version/Model Number

CLPNDA30

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)

-

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

EBF

Product Code Name

MATERIAL, TOOTH SHADE, RESIN

Device Record Status

Public Device Record Key

e7fd6c11-964d-4048-be02-613470642d81

Public Version Date

February 05, 2021

Public Version Number

3

DI Record Publish Date

September 20, 2016

Additional Identifiers

Package DI Number

EBRECLPNDA309

Quantity per Package

1

Contains DI Package

EBRECLPNDA300

Package Discontinue Date

September 20, 2016

Package Status

Not in Commercial Distribution

Package Type

dummy

"BREDENT GMBH & CO. KG" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 38
2 A medical device with a moderate to high risk that requires special controls. 375