Catalog Number

-

Brand Name

NuSmile Pre-Contoured Stainless Steel Crown

Version/Model Number

EUR4606

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

ELZ

Product Code Name

Crown, Preformed

Public Device Record Key

121dcedf-b1b3-4d86-b9d7-709f1387e1be

Public Version Date

October 06, 2021

Public Version Number

1

DI Record Publish Date

September 28, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-