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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 K231097
Device Name Inclusive® Titanium Abutments compatible with: Neoss® ProActive® Narrow, Neoss® ProActive® Standard, MIS® SEVEN®, Zimmer® Eztetic® Implant Systems
Applicant
Prismatik Dentalcraft, Inc.
2144 Michelson Drive
Irvine,  CA  96212
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 Received04/18/2023
Decision Date 11/14/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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