MTA Angelus - Bioceramic reparative cement - MTA White 5G - Angelus Industria de Produtos Odontologicos S A

Duns Number:906943303

Device Description: Bioceramic reparative cement - MTA White 5G

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More Product Details

Catalog Number

1822

Brand Name

MTA Angelus

Version/Model Number

MTA WHITE 5G

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K112046

Product Code Details

Product Code

KIF

Product Code Name

Resin, Root Canal Filling

Device Record Status

Public Device Record Key

623c1d4e-e4de-4e4a-b588-c8c325cf18dc

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 19, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ANGELUS INDUSTRIA DE PRODUTOS ODONTOLOGICOS S A" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 18