Catalog Number

41108US

Brand Name

VarseoSmile Crown plus

Version/Model Number

41108US

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

-

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

K201668,K201668

Product Code

EBF

Product Code Name

Material, Tooth Shade, Resin

Public Device Record Key

6c1f5f2b-d83f-41cf-b65b-cdb454d2b4c9

Public Version Date

September 15, 2021

Public Version Number

3

DI Record Publish Date

July 17, 2020

Package DI Number

EBGO41108US2

Quantity per Package

1

Contains DI Package

EBGO41108US1

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box