Reflect Implant System

Implant, Endosseous, Root-form

Ids - Integrated Dental Systems

The following data is part of a premarket notification filed by Ids - Integrated Dental Systems with the FDA for Reflect Implant System.

Pre-market Notification Details

Device IDK180924
510k NumberK180924
Device Name:Reflect Implant System
ClassificationImplant, Endosseous, Root-form
Applicant ids - Integrated Dental Systems 300 Sylvan Ave. Suite 104 Englewood Cliffs,  NJ  07632
ContactElizabeth Marrero
CorrespondentFloyd Larson
PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego,  CA  92130
Product CodeDZE  
CFR Regulation Number872.3640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-04-09
Decision Date2019-03-29

NIH GUDID Devices

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