Inclusive Abutments

Abutment, Implant, Dental, Endosseous

PRISMATIK DENTALCRAFT, INC.

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

Pre-market Notification Details

Device IDK160979
510k NumberK160979
Device Name:Inclusive Abutments
ClassificationAbutment, Implant, Dental, Endosseous
Applicant PRISMATIK DENTALCRAFT, INC. 2212 DUPONT DRIVE, SUITE P Irvine,  CA  92612
ContactShelly Harris
CorrespondentLinda K. Schulz
PAXMED INTERNATIONAL, LLC 12264 EL CAMINO REAL, SUITE 400 San Diego,  CA  92130
Product CodeNHA  
CFR Regulation Number872.3630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-04-07
Decision Date2016-11-04

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