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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 K233935
Device Name DigiLine Direct Print Aligner System
Applicant
Park Dental Research Corporation
2401 N Commerce St. Suite E
Ardmore,  OK  73401
Applicant Contact Logan Simmons
Correspondent
Prime Path Medtech
1321 Upland Dr.
Suite 6792
Houston,  TX  77043
Correspondent Contact Logan Simmons
Regulation Number872.5470
Classification Product Code
NXC  
Date Received12/14/2023
Decision Date 04/05/2024
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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