Catalog Number

101-1501

Brand Name

Tempro Blue

Version/Model Number

101-1501

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

Product Code

EBF

Product Code Name

Material, Tooth Shade, Resin

Public Device Record Key

0d492446-2ede-4be4-ae99-539b9a6893de

Public Version Date

January 26, 2021

Public Version Number

6

DI Record Publish Date

February 20, 2017

Package DI Number

20210212180016

Quantity per Package

10

Contains DI Package

08809262954173

Package Discontinue Date

January 25, 2021

Package Status

Not in Commercial Distribution

Package Type

-