KLOCKNER ESSENTIAL DENTAL IMPLANTS SYSTEM, MODELS ESSENTIAL CONE (EC), ESSENTIAL SOLID (ES) AND ECK

Implant, Endosseous, Root-form

SOADCO, S.L.

The following data is part of a premarket notification filed by Soadco, S.l. with the FDA for Klockner Essential Dental Implants System, Models Essential Cone (ec), Essential Solid (es) And Eck.

Pre-market Notification Details

Device IDK080224
510k NumberK080224
Device Name:KLOCKNER ESSENTIAL DENTAL IMPLANTS SYSTEM, MODELS ESSENTIAL CONE (EC), ESSENTIAL SOLID (ES) AND ECK
ClassificationImplant, Endosseous, Root-form
Applicant SOADCO, S.L. AV FITER I ROSSELL 4 BIS LOCAL 2 Escaldes-engordany,  AD Ad-700
ContactMaria Mitjaneta
CorrespondentMaria Mitjaneta
SOADCO, S.L. AV FITER I ROSSELL 4 BIS LOCAL 2 Escaldes-engordany,  AD Ad-700
Product CodeDZE  
CFR Regulation Number872.3640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-01-29
Decision Date2008-07-03
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08435451602510 K080224 000
08435451644824 K080224 000
08435451644817 K080224 000
08435451644800 K080224 000
08435451644794 K080224 000
08435451644787 K080224 000
08435451644770 K080224 000
08435451644275 K080224 000
08435451644268 K080224 000
08435451644251 K080224 000
08435451644831 K080224 000
08435451644855 K080224 000
08435451659781 K080224 000
08435451659774 K080224 000
08435451659767 K080224 000
08435451645142 K080224 000
08435451645050 K080224 000
08435451645043 K080224 000
08435451645036 K080224 000
08435451645029 K080224 000
08435451645012 K080224 000
08435451644244 K080224 000
08435451644237 K080224 000
08435451644220 K080224 000
08435451633637 K080224 000
08435451633620 K080224 000
08435451633613 K080224 000
08435451610324 K080224 000
08435451610317 K080224 000
08435451610270 K080224 000
08435451610164 K080224 000
08435451645227 K080224 000
08435451610744 K080224 000
08435451633644 K080224 000
08435451633651 K080224 000
08435451644213 K080224 000
08435451633736 K080224 000
08435451633729 K080224 000
08435451633712 K080224 000
08435451633705 K080224 000
08435451633699 K080224 000
08435451633682 K080224 000
08435451633675 K080224 000
08435451633668 K080224 000
08435451610737 K080224 000
08435451602527 K080224 000
08435451602473 K080224 000
08435451601803 K080224 000
08435451601780 K080224 000
08435451601766 K080224 000
08435451601742 K080224 000
08435451601728 K080224 000
08435451601698 K080224 000
08435451601681 K080224 000
08435451601667 K080224 000
08435451600578 K080224 000
08435451601827 K080224 000
08435451601872 K080224 000
08435451602466 K080224 000
08435451602459 K080224 000
08435451602442 K080224 000
08435451602206 K080224 000
08435451602152 K080224 000
08435451602145 K080224 000
08435451602138 K080224 000
08435451602121 K080224 000
08435451602114 K080224 000
08435451600561 K080224 000
08435451600554 K080224 000
08435451600547 K080224 000
08435451602992 K080224 000
08435451602985 K080224 000
08435451602978 K080224 000
08435451602961 K080224 000
08435451602954 K080224 000
08435451602947 K080224 000
08435451602930 K080224 000
08435451602923 K080224 000
08435451602916 K080224 000
08435451603005 K080224 000
08435451603012 K080224 000
08435451600530 K080224 000
08435451600523 K080224 000
08435451600516 K080224 000
08435451600509 K080224 000
08435451603067 K080224 000
08435451603050 K080224 000
08435451603043 K080224 000
08435451603036 K080224 000
08435451603029 K080224 000
08435451602541 K080224 000

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.