Triceram® - Triceram® dentin D3, 40g / dental ceramic - DENTAURUM GmbH & Co.KG

Duns Number:315427286

Device Description: Triceram® dentin D3, 40g / dental ceramic material

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More Product Details

Catalog Number

-

Brand Name

Triceram®

Version/Model Number

294-243-60

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

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

K011428

Product Code Details

Product Code

EIH

Product Code Name

POWDER, PORCELAIN

Device Record Status

Public Device Record Key

afe638a6-25b8-4c26-90a7-0ea883b48b7a

Public Version Date

July 24, 2018

Public Version Number

4

DI Record Publish Date

September 15, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DENTAURUM 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 2768
2 A medical device with a moderate to high risk that requires special controls. 1745