NuSmile NeoMTA 2 - Tricalcium silicate-based cement for contact with - NUSMILE, LTD.

Duns Number:185497372

Device Description: Tricalcium silicate-based cement for contact with vital pulp and periradicular tissues. Th Tricalcium silicate-based cement for contact with vital pulp and periradicular tissues. This cement is supplied as a powder and gel for mixing prior to use. Cement is radiopaque.

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More Product Details

Catalog Number

none

Brand Name

NuSmile NeoMTA 2

Version/Model Number

NMTA21.0

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)

-

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

bc166e06-26d8-46c5-9802-98b89ea030e1

Public Version Date

December 08, 2021

Public Version Number

3

DI Record Publish Date

September 11, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NUSMILE, LTD." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1091
2 A medical device with a moderate to high risk that requires special controls. 16
U Unclassified 1