Clear Image Aligner - Series 2 - Dual Arch Aligner - SPECIALTY APPLIANCES, LLC

Duns Number:106645484

Device Description: Series 2 - Dual Arch Aligner

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More Product Details

Catalog Number

-

Brand Name

Clear Image Aligner

Version/Model Number

700040

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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"

-

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

-

Product Code Details

Product Code

NXC

Product Code Name

Aligner, Sequential

Device Record Status

Public Device Record Key

629dcece-1fd8-430f-a5fc-e1974a326915

Public Version Date

February 05, 2021

Public Version Number

6

DI Record Publish Date

December 12, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SPECIALTY APPLIANCES, LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 65