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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
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