Catalog Number

23-400-02

Brand Name

NEWGEAR

Version/Model Number

23-400-02

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 31, 2020

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"

Yes

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

K940410

Product Code

DZB

Product Code Name

Headgear, extraoral, orthodontic

Public Device Record Key

78b457d4-e492-4a4e-8956-8820176e7810

Public Version Date

December 23, 2021

Public Version Number

5

DI Record Publish Date

June 26, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-