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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 K151798
Device Name Inclusive Titanium Abutments compatible with: Straumann synOcta Implant System
Applicant
PRISMATIK DENTALCRAFT, INC.
2212 DUPONT DRIVE, SUITE P
IRVINE,  CA  92612
Applicant Contact ARMIN ZEHTABCHI
Correspondent
PRISMATIK DENTALCRAFT, INC.
2212 DUPONT DRIVE, SUITE P
IRVINE,  CA  92612
Correspondent Contact ARMIN ZEHTABCHI
Regulation Number872.3630
Classification Product Code
NHA  
Date Received07/02/2015
Decision Date 11/16/2015
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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