edelweiss VENEER SET 13-23 S up - SET of total 6 pcs VENEERS (1x edelweiss VENEER - edelweiss dentistry products gmbh

Duns Number:300537672

Device Description: SET of total 6 pcs VENEERS (1x edelweiss VENEER 13 S, 1x edelweiss VENEER 12 S, edelweiss SET of total 6 pcs VENEERS (1x edelweiss VENEER 13 S, 1x edelweiss VENEER 12 S, edelweiss VENEER 11 S, edelweiss VENEER 21 S, edelweiss VENEER 22 S and edelweiss VENEER 23 S)

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More Product Details

Catalog Number

-

Brand Name

edelweiss VENEER SET 13-23 S up

Version/Model Number

10100

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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)

-

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

125b4ceb-554d-44ac-ab56-e79e02ec4121

Public Version Date

February 05, 2021

Public Version Number

3

DI Record Publish Date

August 28, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"EDELWEISS DENTISTRY PRODUCTS GMBH" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 145