MTA Flow White - MTA Flow White - ULTRADENT PRODUCTS, INC.

Duns Number:013369913

Device Description: MTA Flow White

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More Product Details

Catalog Number

4980

Brand Name

MTA Flow White

Version/Model Number

4980

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

-

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

877775fc-b58d-499d-a49e-dc2d8519b1d7

Public Version Date

May 18, 2020

Public Version Number

1

DI Record Publish Date

May 09, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ULTRADENT PRODUCTS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 450
2 A medical device with a moderate to high risk that requires special controls. 631
U Unclassified 18