Tetric EvoCeram Bulk Fill - filling materials - IVOCLAR VIVADENT AKTIENGESELLSCHAFT

Duns Number:448015938

Device Description: filling materials

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More Product Details

Catalog Number

639307EN

Brand Name

Tetric EvoCeram Bulk Fill

Version/Model Number

639307EN

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 16, 2019

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

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

EBF

Product Code Name

MATERIAL, TOOTH SHADE, RESIN

Device Record Status

Public Device Record Key

da420419-dd72-4316-8131-935a0a9b9ac5

Public Version Date

July 18, 2019

Public Version Number

3

DI Record Publish Date

December 14, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"IVOCLAR VIVADENT AKTIENGESELLSCHAFT" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 131
2 A medical device with a moderate to high risk that requires special controls. 12768