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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 K170044
Device Name Inclusive Titanium Abutments compatible with: MegaGen AnyRidge Implant System
Applicant
PRISMATIK DENTALCRAFT, INC.
2212 DUPONT DR.
IRVINE,  CA  92612
Applicant Contact MARIA E. WAGNER
Correspondent
PRISMATIK DENTALCRAFT, INC.
2212 DUPONT DR.
IRVINE,  CA  92612
Correspondent Contact MARIA E. WAGNER
Regulation Number872.3630
Classification Product Code
NHA  
Date Received01/05/2017
Decision Date 06/06/2017
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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