Vision-Zirkon - Vision-Zirkon Gingiva Softred 50g - WOHLWEND AG DENTAL MANUFAKTUR

Duns Number:448037775

Device Description: Vision-Zirkon Gingiva Softred 50g

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More Product Details

Catalog Number

2241

Brand Name

Vision-Zirkon

Version/Model Number

2241

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K990790

Product Code Details

Product Code

EIH

Product Code Name

Powder, Porcelain

Device Record Status

Public Device Record Key

1c9236a5-8ad6-428b-828e-14a4587f99f0

Public Version Date

November 04, 2019

Public Version Number

3

DI Record Publish Date

November 20, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"WOHLWEND AG DENTAL MANUFAKTUR" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 948