SM INTERNAL./EXTERNAL IMPLANT SYSTEM

Implant, Endosseous, Root-form

DIO DEPARTMENT DSI, INC.

The following data is part of a premarket notification filed by Dio Department Dsi, Inc. with the FDA for Sm Internal./external Implant System.

Pre-market Notification Details

Device IDK070569
510k NumberK070569
Device Name:SM INTERNAL./EXTERNAL IMPLANT SYSTEM
ClassificationImplant, Endosseous, Root-form
Applicant DIO DEPARTMENT DSI, INC. 13340 E. FIRESTONE BLVD SUITE J Santa Fe Springs,  CA  90670
ContactKenny Lim
CorrespondentKenny Lim
DIO DEPARTMENT DSI, INC. 13340 E. FIRESTONE BLVD SUITE J Santa Fe Springs,  CA  90670
Product CodeDZE  
CFR Regulation Number872.3640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-02-28
Decision Date2007-11-08
Summary:summary

NIH GUDID Devices

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