Oxford MTA Handmix - Endodontic Repair Cement - First Scientific Dental Materials GmbH

Duns Number:341553292

Device Description: Endodontic Repair Cement

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More Product Details

Catalog Number

-

Brand Name

Oxford MTA Handmix

Version/Model Number

40-002

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

KIF

Product Code Name

Resin, Root Canal Filling

Device Record Status

Public Device Record Key

12340648-ea89-4554-bfc8-ff43d114111f

Public Version Date

December 02, 2020

Public Version Number

1

DI Record Publish Date

November 24, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"FIRST SCIENTIFIC DENTAL MATERIALS GMBH" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 24