crea.lign paste Transpa opal - crea.lign paste Transpa opal Light curing - bredent GmbH & Co. KG

Duns Number:341086190

Device Description: crea.lign paste Transpa opal Light curing composite nanofilled 3 g

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More Product Details

Catalog Number

CLPN00T1

Brand Name

crea.lign paste Transpa opal

Version/Model Number

CLPN00T1

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

7da36b20-969e-4eca-b455-2a8539619bc2

Public Version Date

February 05, 2021

Public Version Number

2

DI Record Publish Date

March 21, 2019

Additional Identifiers

Package DI Number

EBRECLPN00T19

Quantity per Package

1

Contains DI Package

EBRECLPN00T10

Package Discontinue Date

March 21, 2019

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