Catalog Number

-

Brand Name

ATOZ Expander Kit

Version/Model Number

ATOZ Expander Kit*10SET

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

DYJ

Product Code Name

Retainer, Screw Expansion, Orthodontic

Public Device Record Key

ca2deed9-b059-42ca-981b-5f1b5868e127

Public Version Date

January 31, 2022

Public Version Number

1

DI Record Publish Date

January 22, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-