Catalog Number

COREEOW

Brand Name

AuraCore Buildup Material

Version/Model Number

Single - Opaque White

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K070702,K070702

Product Code

EBF

Product Code Name

Material, Tooth Shade, Resin

Public Device Record Key

560a903f-85d8-48fd-90ae-f5d3c77044f9

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 04, 2016

Package DI Number

D820COREEOW1

Quantity per Package

4

Contains DI Package

D820ACOREEOW0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-