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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 K223141
Device Name STR8 Clear Aligner
STR8 Oral Care
217 E Cherry Ave
Jonesboro,  AR  72401
Applicant Contact Misee Harris
Prime Path Medtech
1321 Upland Dr.
Suite 6792
Houston,  TX  77043
Correspondent Contact Elisabeth Miller
Regulation Number872.5470
Classification Product Code
Date Received10/04/2022
Decision Date 04/24/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No