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 IDK153099
510k NumberK153099
Device Name:INCLUSIVE TAPERED IMPLANT SYSTEM
ClassificationImplant, Endosseous, Root-form
Applicant PRISMATIK DENTALCRAFT, INC. 2212 DUPONT DRIVE SUITE P Irvine,  CA  92612
ContactArmin Zehtabchi
CorrespondentArmin Zehtabchi
PRISMATIK DENTALCRAFT, INC. 2212 DUPONT DRIVE SUITE P Irvine,  CA  92612
Product CodeDZE  
CFR Regulation Number872.3640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-10-26
Decision Date2016-05-23
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
D745701069IMP00140 K153099 000
D745701206IMP00040 K153099 000
D745701206IMP00030 K153099 000
D745701074PRS00780 K153099 000
D745701074PRS00770 K153099 000
D745701074PRS00760 K153099 000
D745701073PRA01260 K153099 000
D745701073PRA01230 K153099 000
D745701073PRA01200 K153099 000
D745701073PRA01150 K153099 000
D745701073PRA01140 K153099 000
D745701073PRA01070 K153099 000
D745701073PRA01060 K153099 000
D745701073PRA01000 K153099 000
D745701073PRA00990 K153099 000
D745701073PRA00940 K153099 000
D745701073PRA00930 K153099 000
D745701206IMP00050 K153099 000
D745701206IMP00060 K153099 000
D745701069IMP00130 K153099 000
D745701069IMP00120 K153099 000
D745701069IMP00110 K153099 000
D745701069IMP00100 K153099 000
D745701070IMP00360 K153099 000
D745701070IMP00350 K153099 000
D745701070IMP00340 K153099 000
D745701070IMP00330 K153099 000
D745701070IMP00320 K153099 000
D745701207IMP00190 K153099 000
D745701207IMP00060 K153099 000
D745701207IMP00050 K153099 000
D745701207IMP00040 K153099 000
D745701207IMP00030 K153099 000
D745701207IMP00020 K153099 000
D745701206IMP00070 K153099 000
D745701072PRC00860 K153099 000

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