Catalog Number

101-1502

Brand Name

Tempro Yellow

Version/Model Number

101-1502

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

K100413,K100413,K100413,K100413

Product Code

EBF

Product Code Name

Material, Tooth Shade, Resin

Public Device Record Key

4e9ab137-6dfe-4940-a077-9c016b7e8128

Public Version Date

January 26, 2021

Public Version Number

8

DI Record Publish Date

February 20, 2017

Package DI Number

20191201160328

Quantity per Package

100

Contains DI Package

08809262954166

Package Discontinue Date

September 30, 2019

Package Status

Not in Commercial Distribution

Package Type

-