DIO SM IMPLANT SYSTEM

Implant, Endosseous, Root-form

DSI, INC.

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

Pre-market Notification Details

Device IDK080559
510k NumberK080559
Device Name:DIO SM IMPLANT SYSTEM
ClassificationImplant, Endosseous, Root-form
Applicant DSI, INC. 3540 WILSHIRE BLVD SUITE 1104 Los Angeles,  CA  90010
ContactHyungick Kim
CorrespondentHyungick Kim
DSI, INC. 3540 WILSHIRE BLVD SUITE 1104 Los Angeles,  CA  90010
Product CodeDZE  
CFR Regulation Number872.3640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-02-28
Decision Date2008-10-09
Summary:summary

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