Insight Dental System

Implant, Endosseous, Root-form

Insight Dental System

The following data is part of a premarket notification filed by Insight Dental System with the FDA for Insight Dental System.

Pre-market Notification Details

Device IDK170211
510k NumberK170211
Device Name:Insight Dental System
ClassificationImplant, Endosseous, Root-form
Applicant Insight Dental System 4766 Research Drive San Antonio,  TX  78240
ContactMatthew Kaupp
CorrespondentDavid Furr
FDC Services 8708 Capehart Cove Austin,  TX  78733
Product CodeDZE  
CFR Regulation Number872.3640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-01-24
Decision Date2017-04-27
Summary:summary

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