Clear Image Aligner - SPECIALTY APPLIANCES, LLC

Duns Number:106645484

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

Clear Image Aligner

Version/Model Number

70240

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 31, 2017

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

bca27705-232e-4b84-bdaa-e09016ea0c8f

Public Version Date

February 05, 2021

Public Version Number

6

DI Record Publish Date

September 21, 2016

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