ClearCorrect System - The ClearCorrect device is fabricated of clear - Clearcorrect Operating, LLC

Duns Number:016449078

Device Description: The ClearCorrect device is fabricated of clear thin thermoformed polyeurethane plastic in The ClearCorrect device is fabricated of clear thin thermoformed polyeurethane plastic in a sequential series to progressively reposition teeth. Corrective force to straighten teeth is delivered via minor changes into a position in each subsequent aligner.

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More Product Details

Catalog Number

REF-01

Brand Name

ClearCorrect System

Version/Model Number

Aligner (Single-Layer)

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

4a26cd54-a597-4e89-b35b-23b79fb05372

Public Version Date

October 18, 2021

Public Version Number

3

DI Record Publish Date

July 23, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CLEARCORRECT OPERATING, LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 7