Catalog Number

101-0301

Brand Name

Core It Yellow

Version/Model Number

101-0301

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K092572,K092572,K092572,K092572

Product Code

EBF

Product Code Name

Material, Tooth Shade, Resin

Public Device Record Key

67d5c639-75ab-4387-8861-2afde52ed576

Public Version Date

September 06, 2022

Public Version Number

8

DI Record Publish Date

February 20, 2017

Package DI Number

20200205170650

Quantity per Package

100

Contains DI Package

08809262954838

Package Discontinue Date

May 16, 2019

Package Status

Not in Commercial Distribution

Package Type

-