Catalog Number

-

Brand Name

NuSmile ZR Narrow Second Primary Molar Crowns Mini Kit

Version/Model Number

MEKE207L

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

da90b89e-f239-4bcd-9b87-520b26fd714f

Public Version Date

January 21, 2022

Public Version Number

1

DI Record Publish Date

January 13, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-