MIS DENTAL IMPLANT SYSTEM

Implant, Endosseous, Root-form

MIS - IMPLANT TECHNOLOGIES LTD.

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

Pre-market Notification Details

Device IDK040807
510k NumberK040807
Device Name:MIS DENTAL IMPLANT SYSTEM
ClassificationImplant, Endosseous, Root-form
Applicant MIS - IMPLANT TECHNOLOGIES LTD. 278 BROADWAY Elmwood Park,  NJ  07407
ContactMotti Weisman
CorrespondentMotti Weisman
MIS - IMPLANT TECHNOLOGIES LTD. 278 BROADWAY Elmwood Park,  NJ  07407
Product CodeDZE  
CFR Regulation Number872.3640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-03-29
Decision Date2004-06-09
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07290113993617 K040807 000
07290109004242 K040807 000
07290109002668 K040807 000
07290109002651 K040807 000

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