Catalog Number

-

Brand Name

6MS Aligners

Version/Model Number

800-ALN

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K173785

Product Code

NXC

Product Code Name

Aligner, Sequential

Public Device Record Key

5fa1517a-9a68-4098-af81-420f8836b5e1

Public Version Date

February 05, 2021

Public Version Number

2

DI Record Publish Date

July 17, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-