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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 K240240
Device Name Inclusive® Titanium Abutments compatible with: Keystone® Dental PrimaConnex®, Neodent® GM, Straumann® BLX, Implant Direct® Legacy®, Implant Direct® InterActive®, Implant Direct® RePlant® Implant Systems
Applicant
Prismatik Dentalcraft, Inc.
2144 Michelson Drive
Irvine,  CA  92612
Applicant Contact So Hyun Park
Correspondent
Prismatik Dentalcraft, Inc.
2144 Michelson Drive
Irvine,  CA  92612
Correspondent Contact So Hyun Park
Regulation Number872.3630
Classification Product Code
NHA  
Date Received01/30/2024
Decision Date 07/12/2024
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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