Catalog Number

WMA-5L

Brand Name

Widening Mandibular Angle™

Version/Model Number

Size: 5, Left

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

K905268

Product Code

FWP

Product Code Name

Prosthesis, Chin, Internal

Public Device Record Key

7cf080c0-8e99-4b17-8b54-bd0f9e162399

Public Version Date

November 14, 2019

Public Version Number

4

DI Record Publish Date

October 23, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-