Catalog Number

-

Brand Name

Invisalign Signature Smile

Version/Model Number

9025

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 08, 2019

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

-

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

K181739

Product Code

NXC

Product Code Name

Aligner, Sequential

Public Device Record Key

dde7d0f6-ee0b-4e81-802d-e40e196bb83d

Public Version Date

February 05, 2021

Public Version Number

2

DI Record Publish Date

March 01, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-