INTERMEZZO PLUS FIXTURE

Implant, Endosseous, Root-form

MEGAGEN CO., LTD.

The following data is part of a premarket notification filed by Megagen Co., Ltd. with the FDA for Intermezzo Plus Fixture.

Pre-market Notification Details

Device IDK053354
510k NumberK053354
Device Name:INTERMEZZO PLUS FIXTURE
ClassificationImplant, Endosseous, Root-form
Applicant MEGAGEN CO., LTD. 13340 E. FIRESTONE BLVD. SUITE J Santa Fe Springs,  CA  90670
ContactDae Chang
CorrespondentDae Chang
MEGAGEN CO., LTD. 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 Received2005-12-02
Decision Date2006-04-13
Summary:summary

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