Catalog Number

MTMALSA050

Brand Name

MTM® Clear Aligner

Version/Model Number

MTMALSA050

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 19, 2021

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

-

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

40e01f7c-1c4d-4ca0-bb96-6da18963392a

Public Version Date

February 22, 2021

Public Version Number

4

DI Record Publish Date

February 09, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-