DENTIS DENTAL IMPLANT SYSTEM

Implant, Endosseous, Root-form

DENTIS CO. LTD.

The following data is part of a premarket notification filed by Dentis Co. Ltd. with the FDA for Dentis Dental Implant System.

Pre-market Notification Details

Device IDK073486
510k NumberK073486
Device Name:DENTIS DENTAL IMPLANT SYSTEM
ClassificationImplant, Endosseous, Root-form
Applicant DENTIS CO. LTD. 13340 E FIRESTONE BLVD SUITE J Santa Fe Springs,  CA  90670
ContactChang Dae Kyu
CorrespondentChang Dae Kyu
DENTIS 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 Received2007-12-12
Decision Date2008-04-04
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00880616910030 K073486 000
08806169100801 K073486 000

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