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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Aligner, Sequential
510(k) Number K201450
Device Name Straight T Clear Dental Aligner
Applicant
Straight T, Inc.
16952 W. Bell Rd. #301
Surprise,  AZ  85374
Applicant Contact Minh Trinh
Correspondent
Compliance Systems International, LLC
1083 Delaware Ave.
Buffalo,  NY  14209
Correspondent Contact Robert O. Dean
Regulation Number872.5470
Classification Product Code
NXC  
Date Received06/01/2020
Decision Date 09/10/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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