Catalog Number

-

Brand Name

ORTHO ALIGNER TRAY SEATERS

Version/Model Number

6070540031

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

ECS

Product Code Name

Pusher, Band, Orthodontic

Public Device Record Key

edbcb90c-fcce-40ab-81a3-f073aa783502

Public Version Date

September 16, 2022

Public Version Number

1

DI Record Publish Date

September 08, 2022

Package DI Number

D89260705400313

Quantity per Package

2000

Contains DI Package

D89260705400312

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case