Catalog Number

S338

Brand Name

SmarTemp®

Version/Model Number

S338

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

K991270

Product Code

EBG

Product Code Name

Crown And Bridge, Temporary, Resin

Public Device Record Key

0f0f060a-7102-4741-b112-1a9015f4cd01

Public Version Date

October 29, 2021

Public Version Number

3

DI Record Publish Date

October 26, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-