Catalog Number

846

Brand Name

MTA REPAIR HP

Version/Model Number

MTA REPAIR HP 0.425 g

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K151047

Product Code

KIF

Product Code Name

Resin, Root Canal Filling

Public Device Record Key

9ed1ad0c-6ff3-4757-969c-7d081da5f327

Public Version Date

November 17, 2020

Public Version Number

1

DI Record Publish Date

November 09, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-