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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Anti-Snoring
510(k) Number K252976
Device Name Park Dental Nylon MAD
Applicant
Park Dental Research Corp.
2401 N. Commerce
Suite E
Ardmore,  OK  73401
Applicant Contact Ron Bulard
Correspondent
Prime Path Medtech
1321 Upland Dr.
Suite 6792
Houston,  TX  77043
Correspondent Contact Jennifer Day
Regulation Number872.5570
Classification Product Code
LRK  
Subsequent Product Code
LQZ  
Date Received09/17/2025
Decision Date 12/18/2025
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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