FDA 510(k) Application Details - K210320

Device Classification Name Aligner, Sequential

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510(K) Number K210320
Device Name Aligner, Sequential
Applicant ClearCorrect LLC
21 Cypress Boulevard, Suite 1010
Round Rock, TX 78665 US
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Contact Christopher Klaczyk
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Regulation Number 872.5470

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Classification Product Code NXC
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Date Received 02/04/2021
Decision Date 08/06/2021
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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