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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Abutment, Implant, Dental, Endosseous
510(k) Number K252582
Device Name Inclusive® Titanium Abutments compatible with: Camlog® CONELOG® Implant System, Dentium® NR Line Implant Systems
Applicant
Prismatik Dentalcraft, Inc.
2144 Michelson Dr.
Irvine,  CA  92612
Applicant Contact So Hyun Park
Correspondent
Prismatik Dentalcraft, Inc.
2144 Michelson Dr.
Irvine,  CA  92612
Correspondent Contact So Hyun Park
Regulation Number872.3630
Classification Product Code
NHA  
Date Received08/15/2025
Decision Date 11/18/2025
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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