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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 K180648
Device Name Park Dental Research Aligners
Applicant
Park Dental Research Corporation
2401 N. Commerce St Suite E
Ardmore,  OK  73401
Applicant Contact Ronald A. Bulard
Correspondent
Blackwell Device Consulting
P.O. Box 718
Gresham,  OR  97030 -0172
Correspondent Contact Angela Blackwell
Regulation Number872.5470
Classification Product Code
NXC  
Date Received03/13/2018
Decision Date 01/08/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
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