Catalog Number

41103US

Brand Name

VarseoSmile Temp

Version/Model Number

41103US

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

Yes

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

K193553,K193553

Product Code

EBG

Product Code Name

Crown And Bridge, Temporary, Resin

Public Device Record Key

6f24032e-aab8-4cea-a0c8-a143c31f6733

Public Version Date

October 29, 2021

Public Version Number

3

DI Record Publish Date

May 27, 2020

Package DI Number

EBGO41103US2

Quantity per Package

1

Contains DI Package

EBGO41103US1

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box