Invisalign Deluxe Smile - Sequential Aligner - ALIGN TECHNOLOGY, INC.

Duns Number:013831768

Device Description: Sequential Aligner

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More Product Details

Catalog Number

-

Brand Name

Invisalign Deluxe Smile

Version/Model Number

9019

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

-

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 Details

Product Code

NXC

Product Code Name

Aligner, Sequential

Device Record Status

Public Device Record Key

6141639d-50b5-4c60-81f2-15921d19beac

Public Version Date

February 05, 2021

Public Version Number

2

DI Record Publish Date

June 15, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ALIGN TECHNOLOGY, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 4
2 A medical device with a moderate to high risk that requires special controls. 81