INCLUSIVE TAPERED IMPLANT SYSTEM

Implant, Endosseous, Root-form

PRISMATIK DENTALCRAFT, INC.

The following data is part of a premarket notification filed by Prismatik Dentalcraft, Inc. with the FDA for Inclusive Tapered Implant System.

Pre-market Notification Details

Device IDK121406
510k NumberK121406
Device Name:INCLUSIVE TAPERED IMPLANT SYSTEM
ClassificationImplant, Endosseous, Root-form
Applicant PRISMATIK DENTALCRAFT, INC. 2212 DUPONT DR., ST P Irvine,  CA  92612
ContactArmin Zehtabchi
CorrespondentArmin Zehtabchi
PRISMATIK DENTALCRAFT, INC. 2212 DUPONT DR., ST P Irvine,  CA  92612
Product CodeDZE  
CFR Regulation Number872.3640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-05-10
Decision Date2013-02-22
Summary:summary

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