ClearCorrect System

Aligner, Sequential

ClearCorrect LLC

The following data is part of a premarket notification filed by Clearcorrect Llc with the FDA for Clearcorrect System.

Pre-market Notification Details

Device IDK210320
510k NumberK210320
Device Name:ClearCorrect System
ClassificationAligner, Sequential
Applicant ClearCorrect LLC 21 Cypress Boulevard, Suite 1010 Round Rock,  TX  78665
ContactChristopher Klaczyk
CorrespondentChristopher Klaczyk
ClearCorrect LLC 21 Cypress Boulevard, Suite 1010 Round Rock,  TX  78665
Product CodeNXC  
CFR Regulation Number872.5470 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-02-04
Decision Date2021-08-06

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