MULTILINK HYBRID ABUTMENT - Multilink Hybrid Abutment Refill HO 0 - IVOCLAR VIVADENT AKTIENGESELLSCHAFT

Duns Number:448015938

Device Description: Multilink Hybrid Abutment Refill HO 0

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More Product Details

Catalog Number

-

Brand Name

MULTILINK HYBRID ABUTMENT

Version/Model Number

647182AN

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

-

Product Code Details

Product Code

EMA

Product Code Name

CEMENT, DENTAL

Device Record Status

Public Device Record Key

4076677a-6c69-4503-8e03-33675791f15f

Public Version Date

December 17, 2018

Public Version Number

1

DI Record Publish Date

November 16, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"IVOCLAR VIVADENT AKTIENGESELLSCHAFT" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 131
2 A medical device with a moderate to high risk that requires special controls. 12768