DD Bio ZW iso color - DD Bio Z are dental mill blanks made from - Dental Direkt GmbH

Duns Number:313214171

Device Description: DD Bio Z are dental mill blanks made from zirconium dioxide for the manufacture of dental DD Bio Z are dental mill blanks made from zirconium dioxide for the manufacture of dental prostheses. DD Bio Z can be used for all dental constructions with up to two bridge elements in the front and side tooth area.

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More Product Details

Catalog Number

G52620000

Brand Name

DD Bio ZW iso color

Version/Model Number

98H25 2000

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

-

Product Code Details

Product Code

EIH

Product Code Name

Powder, Porcelain

Device Record Status

Public Device Record Key

7fd99258-5b1f-4e27-93e0-4bdc69022f18

Public Version Date

July 24, 2018

Public Version Number

3

DI Record Publish Date

October 05, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DENTAL DIREKT GMBH" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 677