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
EAGNTA6000530 K141159 000
EAGNTA40040NH30 K141159 000
EAGNTA40040NH20 K141159 000
EAGNTA4004020 K141159 000
EAGNTA40020NH30 K141159 000
EAGNTA40020NH20 K141159 000
EAGNTA4002020 K141159 000
EAGNTA40005NH20 K141159 000
EAGNTA30060NH20 K141159 000
EAGNTA4006020 K141159 000
EAGNTA40060NH20 K141159 000
EAGNTA50060NH30 K141159 000
EAGNTA50060NH20 K141159 000
EAGNTA50040NH30 K141159 000
EAGNTA50040NH20 K141159 000
EAGNTA50020NH30 K141159 000
EAGNTA50020NH20 K141159 000
EAGNTA50005NH30 K141159 000
EAGNTA40060NH30 K141159 000
EAGNTA30040NH20 K141159 000
EAGNTA30020NH20 K141159 000
EAGNSK06K3PRO0 K141159 000
EAGNOTK3PRO3SET0 K141159 000
EAGNOTK3PRO3LSET0 K141159 000
EAGNOTK3PRO2SET0 K141159 000
EAGNOTK3PRO2LSET0 K141159 000
EAGNMBS4000303PRO0 K141159 000
EAGNMBS4000302PRO0 K141159 000
EAGNMBS4000203PRO0 K141159 000
EAGNMBS4000202PRO0 K141159 000
EAGNPA40000 K141159 000
EAGNPA4010150 K141159 000
EAGNSK03K3PRO0 K141159 000
EAGNSK02K3PRO0 K141159 000
EAGNSK01K3PROZB0 K141159 000
EAGNSK01K3PROKB0 K141159 000
EAGNPA5015150 K141159 000
EAGNPA5010150 K141159 000
EAGNPA50000 K141159 000
EAGNPA4015150 K141159 000
EAGNMBS4000103PRO0 K141159 000
EAGNTA6002020 K141159 000
EAGNAA500005H3PRO0 K141159 000
EAGNAA401015H2PRO0 K141159 000
EAGNAA401005H2PRO0 K141159 000
EAGNAA400045H2PRO0 K141159 000
EAGNAA400030H2PRO0 K141159 000
EAGNAA400015H2PRO0 K141159 000
EAGNAA400005H2PRO0 K141159 000
EAGNVSK3K0 K141159 000
EAGNVSK2K0 K141159 000
EAGNAA401030H2PRO0 K141159 000
EAGNAA401045H2PRO0 K141159 000
EAGNAA403045H2PRO0 K141159 000
EAGNAA403030H2PRO0 K141159 000
EAGNAA403015H2PRO0 K141159 000
EAGNAA403005H2PRO0 K141159 000
EAGNAA402045H2PRO0 K141159 000
EAGNAA402030H2PRO0 K141159 000
EAGNAA402015H2PRO0 K141159 000
EAGNAA402005H2PRO0 K141159 000
EAGNVBAOTK500 K141159 000
EAGNVBALA500 K141159 000
EAGNVBAGTK500 K141159 000
EAGNTA8002030 K141159 000
EAGNTA60060NH30 K141159 000
EAGNTA6006030 K141159 000
EAGNTA6006020 K141159 000
EAGNTA60040NH30 K141159 000
EAGNTA6004030 K141159 000
EAGNTA6004020 K141159 000
EAGNTA60020NH30 K141159 000
EAGNTA8004030 K141159 000
EAGNTA8006030 K141159 000
EAGNVBA50000PKKPK0 K141159 000
EAGNVBA50000GV0 K141159 000
EAGNTPE3K0 K141159 000
EAGNTPE2K0 K141159 000
EAGNTPA4514H3PROT0 K141159 000
EAGNTPA4514H3PROP0 K141159 000
EAGNTPA3514H2PROT0 K141159 000
EAGNTPA3514H2PROP0 K141159 000
EAGNTA6002030 K141159 000
EAGNMBS4000102PRO0 K141159 000
EAGN50009K3PROR9 K141159 000
EAGN45008K3PROS9 K141159 000
EAGN45008K3PROR9 K141159 000
EAGN40017K3PROR9 K141159 000
EAGN40015K3PROR9 K141159 000
EAGN40013K3PROS9 K141159 000
EAGN40013K3PROR9 K141159 000
EAGN40011K3PROS9 K141159 000
EAGN40011K3PROR9 K141159 000
EAGN45009K3PROR9 K141159 000
EAGN45009K3PROS9 K141159 000
EAGN50008K3PROS9 K141159 000
EAGN50008K3PROR9 K141159 000
EAGN45017K3PROR9 K141159 000
EAGN45015K3PROR9 K141159 000
EAGN45013K3PROS9 K141159 000
EAGN45013K3PROR9 K141159 000
EAGN45011K3PROS9 K141159 000
EAGN45011K3PROR9 K141159 000
EAGN40009K3PROS9 K141159 000
EAGN40009K3PROR9 K141159 000
EAGN40008K3PROS9 K141159 000
EAGN30015K3PROR9 K141159 000
EAGN30013K3PROS9 K141159 000
EAGN30013K3PROR9 K141159 000
EAGN30011K3PROS9 K141159 000
EAGN30011K3PROR9 K141159 000
EAGN30009K3PROS9 K141159 000
EAGN30009K3PROR9 K141159 000
EAGNEATK40KSET0 K141159 000
EAGN30017K3PROR9 K141159 000
EAGN35009K3PROR9 K141159 000
EAGN40008K3PROR9 K141159 000
EAGN35017K3PROR9 K141159 000
EAGN35015K3PROR9 K141159 000
EAGN35013K3PROS9 K141159 000
EAGN35013K3PROR9 K141159 000
EAGN35011K3PROS9 K141159 000
EAGN35011K3PROR9 K141159 000
EAGN35009K3PROS9 K141159 000
EAGNBPSXP3502030 K141159 000
EAGN50009K3PROS9 K141159 000
EAGNMBOTK163PRO0 K141159 000
EAGNHSVBA160 K141159 000
EAGNGKPA500700 K141159 000
EAGNGKPA500600 K141159 000
EAGNGKPA400600 K141159 000
EAGNGKPA400500 K141159 000
EAGNFLAAS160 K141159 000
EAGNFLA010 K141159 000
EAGNETSK3PRO30 K141159 000
EAGNKSAK500 K141159 000
EAGNKSAPT400 K141159 000
EAGNMBOTK142PRO0 K141159 000
EAGNMBLA163PRO0 K141159 000
EAGNMBLA142PRO0 K141159 000
EAGNMBGTK163PRO0 K141159 000
EAGNMBGTK142PRO0 K141159 000
EAGNLAK3PRO30 K141159 000
EAGNLAK3PRO20 K141159 000
EAGNKSAPT500 K141159 000
EAGNETSK3PRO20 K141159 000
EAGNETK3PRO3SET0 K141159 000
EAGNETK3PRO3LSET0 K141159 000
EAGNCGSBK3PRO20 K141159 000
EAGN60009K3PROS9 K141159 000
EAGN60009K3PROR9 K141159 000
EAGN60008K3PROS9 K141159 000
EAGN60008K3PROR9 K141159 000
EAGN50013K3PROS9 K141159 000
EAGN50013K3PROR9 K141159 000
EAGN50011K3PROS9 K141159 000
EAGNCGSBK3PRO2PK0 K141159 000
EAGNCGSBK3PRO30 K141159 000
EAGNETK3PRO2SET0 K141159 000
EAGNETK3PRO2LSET0 K141159 000
EAGNEAZTS140 K141159 000
EAGNEATK50K0 K141159 000
EAGNEATK40K0 K141159 000
EAGNEAKA500 K141159 000
EAGNEAKA400 K141159 000
EAGNCGSBK3PRO3PK0 K141159 000
EAGN50011K3PROR9 K141159 000
EAGNAA500015H3PRO0 K141159 000
EAGNMBA400020NH3PRO0 K141159 000
EAGNKSA500025H3PRO0 K141159 000
EAGNKSA500015H3PRO0 K141159 000
EAGNKSA500005H3PRO0 K141159 000
EAGNKSA402025H2PRO0 K141159 000
EAGNKSA402015H2PRO0 K141159 000
EAGNKSA402005H2PRO0 K141159 000
EAGNKSA401025H2PRO0 K141159 000
EAGNKSA401015H2PRO0 K141159 000
EAGNKSA501005H3PRO0 K141159 000
EAGNKSA501015H3PRO0 K141159 000
EAGNMBA400020NH2PRO0 K141159 000
EAGNMBA400010NH3PRO0 K141159 000
EAGNMBA400010NH2PRO0 K141159 000
EAGNKSAK400 K141159 000
EAGNKSA502025H3PRO0 K141159 000
EAGNKSA502015H3PRO0 K141159 000
EAGNKSA502005H3PRO0 K141159 000
EAGNKSA501025H3PRO0 K141159 000
EAGNKSA401005H2PRO0 K141159 000
EAGNKSA400025H2PRO0 K141159 000
EAGNKSA400015H2PRO0 K141159 000
EAGNFLA45000NH30 K141159 000
EAGNFLA45000NH20 K141159 000
EAGNFLA35000NH30 K141159 000
EAGNFLA35000NH20 K141159 000
EAGNFLA25000NH30 K141159 000
EAGNFLA25000NH20 K141159 000
EAGNFLA15000NH30 K141159 000
EAGNFLA15000NH20 K141159 000
EAGNFLAA6001530 K141159 000
EAGNKKA0500NH2PRO0 K141159 000
EAGNKSA400005H2PRO0 K141159 000
EAGNKKA4500NH3PRO0 K141159 000
EAGNKKA4500NH2PRO0 K141159 000
EAGNKKA3000NH3PRO0 K141159 000
EAGNKKA3000NH2PRO0 K141159 000
EAGNKKA1500NH3PRO0 K141159 000
EAGNKKA1500NH2PRO0 K141159 000
EAGNKKA0500NH3PRO0 K141159 000
EAGNFLA05000NH30 K141159 000
EAGNMBA400030NH2PRO0 K141159 000
EAGNVBALK010 K141159 000
EAGNVBA502035H2PRO0 K141159 000
EAGNVBA502025H3PRO0 K141159 000
EAGNVBA502025H2PRO0 K141159 000
EAGNVBA502015H3PRO0 K141159 000
EAGNVBA502015H2PRO0 K141159 000
EAGNVBA502005H3PRO0 K141159 000
EAGNVBA502005H2PRO0 K141159 000
EAGNVBA500035H3PRO0 K141159 000
EAGNVBA502035H3PRO0 K141159 000
EAGNVBA503005H2PRO0 K141159 000
EAGNVBAKK010 K141159 000
EAGNVBA503035H3PRO0 K141159 000
EAGNVBA503035H2PRO0 K141159 000
EAGNVBA503025H3PRO0 K141159 000
EAGNVBA503025H2PRO0 K141159 000
EAGNVBA503015H3PRO0 K141159 000
EAGNVBA503015H2PRO0 K141159 000
EAGNVBA503005H3PRO0 K141159 000
EAGNVBA500035H2PRO0 K141159 000
EAGNVBA500025H3PRO0 K141159 000
EAGNVBA500025H2PRO0 K141159 000
EAGNRA60000 K141159 000
EAGNRA50000 K141159 000
EAGNRA45000 K141159 000
EAGNRA40000 K141159 000
EAGNRA35000 K141159 000
EAGNRA30000 K141159 000
EAGNMBTH163PRO0 K141159 000
EAGNMBTH142PRO0 K141159 000
EAGNUCLA400015H2PRO0 K141159 000
EAGNUCLA500015H3PRO0 K141159 000
EAGNVBA500015H3PRO0 K141159 000
EAGNVBA500015H2PRO0 K141159 000
EAGNVBA50000PKKT0 K141159 000
EAGNVBA50000PKKPOM0 K141159 000
EAGNVBA50000PKKHSLA0 K141159 000
EAGNVBA50000PKKELITOR0 K141159 000
EAGNVBA500005H3PRO0 K141159 000
EAGNVBA500005H2PRO0 K141159 000
EAGNMBA400030NH3PRO0 K141159 000
EAGNFLA05000NH20 K141159 000
EAGNEAK401015H2PRO0 K141159 000
EAGNCS40000520 K141159 000
EAGNCGC0015H3PROP2TC0 K141159 000
EAGNCGC0015H3PROP1TC0 K141159 000
EAGNCGC0015H3PROM1TC0 K141159 000
EAGNCGC0015H2PROP2TC0 K141159 000
EAGNCGC0005H3PROP2TC0 K141159 000
EAGNCGC0005H3PROP1TC0 K141159 000
EAGNCGC0005H3PROM1TC0 K141159 000
EAGNCS40000530 K141159 000
EAGNCS40001520 K141159 000
EAGNEAK401005H2PRO0 K141159 000
EAGNEAK400045H2PRO0 K141159 000
EAGNEAK400030H2PRO0 K141159 000
EAGNEAK400015H2PRO0 K141159 000
EAGNEAK400005H2PRO0 K141159 000
EAGNCS45001520 K141159 000
EAGNCS45000530 K141159 000
EAGNCS40001530 K141159 000
EAGNCADUNI1600153PRO0 K141159 000
EAGNCADUNI1600152PRO0 K141159 000
EAGNCADUNI1600053PRO0 K141159 000
EAGNAA502030H3PRO0 K141159 000
EAGNAA502015H3PRO0 K141159 000
EAGNAA502005H3PRO0 K141159 000
EAGNAA501045H3PRO0 K141159 000
EAGNAA501030H3PRO0 K141159 000
EAGNAA501015H3PRO0 K141159 000
EAGNAA501005H3PRO0 K141159 000
EAGNAA500045H3PRO0 K141159 000
EAGNAA502045H3PRO0 K141159 000
EAGNAA503005H3PRO0 K141159 000
EAGNCADUNI1600052PRO0 K141159 000
EAGNCADUNI1000053PRO0 K141159 000
EAGNCADUNI1000052PRO0 K141159 000
EAGNCAD1400053PRO0 K141159 000
EAGNCAD1400052PRO0 K141159 000
EAGNAA503045H3PRO0 K141159 000
EAGNAA503030H3PRO0 K141159 000
EAGNAA503015H3PRO0 K141159 000
EAGNAA500030H3PRO0 K141159 000
EAGNEAK401030H2PRO0 K141159 000
EAGNFF800015H3PRO0 K141159 000
EAGNEAZTV502005H3PRO0 K141159 000
EAGNEAZTV501015H3PRO0 K141159 000
EAGNEAZTV501005H3PRO0 K141159 000
EAGNEAZTV500015H3PRO0 K141159 000
EAGNEAZTV500005H3PRO0 K141159 000
EAGNEAZTV403015H2PRO0 K141159 000
EAGNEAZTV403005H2PRO0 K141159 000
EAGNEAZTV402015H2PRO0 K141159 000
EAGNEAZTV502015H3PRO0 K141159 000
EAGNEAZTV503005H3PRO0 K141159 000
EAGNFF800005H3PRO0 K141159 000
EAGNFF600015H3PRO0 K141159 000
EAGNFF600015H2PRO0 K141159 000
EAGNFF600005H3PRO0 K141159 000
EAGNFF600005H2PRO0 K141159 000
EAGNFF500015H2PRO0 K141159 000
EAGNFF500005H2PRO0 K141159 000
EAGNEAZTV503015H3PRO0 K141159 000
EAGNEAZTV402005H2PRO0 K141159 000
EAGNEAZTV401015H2PRO0 K141159 000
EAGNEAZTV401005H2PRO0 K141159 000
EAGNEAK500045H3PRO0 K141159 000
EAGNEAK500030H3PRO0 K141159 000
EAGNEAK500015H3PRO0 K141159 000
EAGNEAK500005H3PRO0 K141159 000
EAGNEAK401545H2PRO0 K141159 000
EAGNEAK401530H2PRO0 K141159 000
EAGNEAK401515H2PRO0 K141159 000
EAGNEAK401505H2PRO0 K141159 000
EAGNEAK501005H3PRO0 K141159 000
EAGNEAK501015H3PRO0 K141159 000
EAGNEAZTV400015H2PRO0 K141159 000
EAGNEAZTV400005H2PRO0 K141159 000
EAGNEAK501545H3PRO0 K141159 000
EAGNEAK501530H3PRO0 K141159 000
EAGNEAK501515H3PRO0 K141159 000
EAGNEAK501505H3PRO0 K141159 000
EAGNEAK501045H3PRO0 K141159 000
EAGNEAK501030H3PRO0 K141159 000
EAGNEAK401045H2PRO0 K141159 000
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.