VITAVM LC - VITAVM®LC ONE COLOR KIT 3M2 - flow Edition - Vita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co Kommanditgesellschaft

Duns Number:315165357

Device Description: VITAVM®LC ONE COLOR KIT 3M2 - flow Edition

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

VITAVM LC

Version/Model Number

CVLCFTKG3M2

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

K961434

Product Code Details

Product Code

EBF

Product Code Name

MATERIAL, TOOTH SHADE, RESIN

Device Record Status

Public Device Record Key

fd4c35ab-2fc9-4a8f-8aa0-5ddd99343ac4

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

February 18, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"VITA - ZAHNFABRIK H. RAUTER GESELLSCHAFT MIT BESCHRÄNKTER HAFTUNG & CO KOMMANDITGESELLSCHAFT" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 11685