Catalog Number

-

Brand Name

HARDCORE® - CORE BUILD-UP MATERIAL - DUAL CURE, FLUORIDE RELEASING

Version/Model Number

HCR

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 01, 2019

Issuing Agency

In HIBCC

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

Yes

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

-

FDA Premarket Submission

K922755

Product Code

EBF

Product Code Name

Material, Tooth Shade, Resin

Public Device Record Key

c4fe1000-a1a6-4aef-9c54-d009ba03c924

Public Version Date

November 26, 2019

Public Version Number

4

DI Record Publish Date

August 11, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-