Catalog Number

-

Brand Name

Clear Image Aligner Prime (Z-FLX): Lower

Version/Model Number

700093

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

-

Product Code

NXC

Product Code Name

Aligner, Sequential

Public Device Record Key

63b9d3e7-66bc-48af-b4eb-abca178e2335

Public Version Date

June 22, 2022

Public Version Number

1

DI Record Publish Date

June 14, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-