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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 K142115
Device Name INCLUSIVE TITANIUM ABUTMENTS COMPATIBLE WITH: ZIMMER, BIOMET 3I, AND NOBEL BIOCARE IMPLANT
Applicant
PRISMATIK DENTALCRAFT, INC.
2212 DUPONT DRIVE, SUITE P
IRVINE,  CA  92612
Applicant Contact BRANDON SHEPARD
Correspondent
PRISMATIK DENTALCRAFT, INC.
2212 DUPONT DRIVE, SUITE P
IRVINE,  CA  92612
Correspondent Contact BRANDON SHEPARD
Regulation Number872.3630
Classification Product Code
NHA  
Date Received08/04/2014
Decision Date 11/13/2014
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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