KONUS DENTAL IMPLANT SYSTEM

Implant, Endosseous, Root-form

ARGON MED. PRODUCTIONS VERTRIEBS GESELLSCHAFT MBH

The following data is part of a premarket notification filed by Argon Med. Productions Vertriebs Gesellschaft Mbh with the FDA for Konus Dental Implant System.

Pre-market Notification Details

Device IDK141159
510k NumberK141159
Device Name:KONUS DENTAL IMPLANT SYSTEM
ClassificationImplant, Endosseous, Root-form
Applicant ARGON MED. PRODUCTIONS VERTRIEBS GESELLSCHAFT MBH 1000 CORPORATE DR Marshfield,  WI  54449
ContactLinda Saylor
CorrespondentLinda Saylor
ARGON MED. PRODUCTIONS VERTRIEBS GESELLSCHAFT MBH 1000 CORPORATE DR Marshfield,  WI  54449
Product CodeDZE  
CFR Regulation Number872.3640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-05-05
Decision Date2015-03-11
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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EAGNTA4006020 K141159 000
EAGNTA40040NH30 K141159 000
EAGNTA40040NH20 K141159 000
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