Catalog Number

TCB-ST-A3

Brand Name

Select Supratemp

Version/Model Number

TCB-ST-A3

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

EBG

Product Code Name

Crown And Bridge, Temporary, Resin

Public Device Record Key

2fc9ca5a-e717-4e61-b787-e2fa211caf51

Public Version Date

October 29, 2021

Public Version Number

2

DI Record Publish Date

April 04, 2018

Package DI Number

17540208000339

Quantity per Package

1

Contains DI Package

07540208000332

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton