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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 K160979
Device Name Inclusive Abutments
Applicant
Prismatik Dentalcraft, Inc.
2212 Dupont Dr., Suite P
Irvine,  CA  92612
Applicant Contact SHELLY HARRIS
Correspondent
Paxmed International, LLC
12264 El Camino Real
Suite 400
San Diego,  CA  92130
Correspondent Contact LINDA K. SCHULZ
Regulation Number872.3630
Classification Product Code
NHA  
Date Received04/07/2016
Decision Date 11/04/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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