HIT Clear Aligner

Aligner, Sequential

CDB Corporation

The following data is part of a premarket notification filed by Cdb Corporation with the FDA for Hit Clear Aligner.

Pre-market Notification Details

Device IDK210613
510k NumberK210613
Device Name:HIT Clear Aligner
ClassificationAligner, Sequential
Applicant CDB Corporation 9201 Industrial Park Boulevard Leland,  NC  28451
ContactLeah M Lehman
CorrespondentLeah M Lehman
CDB Corporation 9201 Industrial Boulevard, NE Leland,  NC  28451
Product CodeNXC  
CFR Regulation Number872.5470 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-03-01
Decision Date2021-06-04

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