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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 K190394
Device Name SunClear Aligner system
Applicant
Sun Dental Laboratories, LLC
1800 9th Ave N
St. Petersburg,  FL  33713
Applicant Contact Derek Diasti
Correspondent
Sun Dental Laboratories, LLC / ProMedic, LLC
131 Bay Point Dr. NE
St. Petersburg,  FL  33704
Correspondent Contact Paul Dryden
Regulation Number872.5470
Classification Product Code
NXC  
Subsequent Product Code
DYW  
Date Received02/19/2019
Decision Date 12/16/2019
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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