Straight T Clear Dental Aligner

Aligner, Sequential

Straight T, Inc.

The following data is part of a premarket notification filed by Straight T, Inc. with the FDA for Straight T Clear Dental Aligner.

Pre-market Notification Details

Device IDK201450
510k NumberK201450
Device Name:Straight T Clear Dental Aligner
ClassificationAligner, Sequential
Applicant Straight T, Inc. 16952 W. Bell Rd #301 Surprise,  AZ  85374
ContactMinh Trinh
CorrespondentRobert O. Dean
Compliance Systems International, LLC. 1083 Delaware Ave. Buffalo,  NY  14209
Product CodeNXC  
CFR Regulation Number872.5470 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-01
Decision Date2020-09-10

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