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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthodontic Software
510(k) Number K232429
Device Name Titan Dental Design
Applicant
ClearAdvance, LLC
18 Endeavor, STE 107
Irvine,  CA  92618
Applicant Contact Frank Puig
Correspondent
Prime Path Medtech
1321 Upland Dr. Suite 6792
Houston,  TX  77043
Correspondent Contact Logan Simmons
Regulation Number872.5470
Classification Product Code
PNN  
Subsequent Product Code
LLZ  
Date Received08/11/2023
Decision Date 10/13/2023
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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