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Direktifi 93l42lEEC,EkII, Madde4
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KayrtNo.:HD 600789310001
006
RaporNo: 30791610
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Uretici
: SterngoldDentalLLC
23 Frank MossbergDrive
Attleboro MA 02703
ABD
Kapsam
tasanmt,daltttmr,geligtirilmesive iiretimi
: Dentalmalzemelerin
tirtinler: Ekebakrn.
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Bu sertifika,HD 600236570001sayrhonaysertifikasrrun
Gegerlilik tarih: 02.08.2017
OnaylanmrgKurulugigbu belgeyle 93l42lEECsayrhdirektifin 4. bdltimti harig Ek II
gereksinimlerininbelirtilen iiriinler igin kargrlandrlrmonaylar. Yukanda adr gegen
iiretici, yukandabahsedilendirektifinbdliim 5, Ek II ile tammlananperiyodikdenetime
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Bildirilmiq Kurulug
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Yiirtirliik Tarihi: 24.09.2012
Tarih:24.09.2012
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Direktifi 93l42tEEC,Ek II, Madde 4
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Medikal Cihazlar
Kayrt No.: HD 60078931
0001
RaporNo: 30791610
006
Uretici
: SterngoldDentalLLC
23 Frank MossbergDrive
AttleboroMA 02703
ABD
Kapsam
: Uriinler:
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Dentalimplant iiriinleri
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Dentalproteziirtinleri
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Asitle yakmahDentalimplantsistemleri
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Seramik,tagve kdprtidentallagrmlar
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Sternrestoratifsistemler
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Tarih:24.09.2012
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EC Certificate
Directive93l42lEECAnnex ll, excluding$ection4
Full QualityAssurance$ystem
MedicalDevices
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lP1'5072
Registration
0001
No.: HD 60078931
006
30791610
ReportNo.:
Manufacturer:
Products:
$terngoldDentalLLC
23 FrankMossbergDrive
AttleboroMA 02703
USA
Desi.gn arrd Develcrpment,
of Dental MaLerials
Froducts:
see aLtachment
Replaces Approval,
ExpiryDate:
production
Registracjon
aud Dj-slribution
No.:
IID 50023557 0001
2477 -48^02
The NotifiedBody herebydeclaresthat the r*quirementsof Annexll, excludingsectlon4 of the directive
havebeenmet for the listcd products,The abovanamadmanufacturerhas established
93l42lEEC
and appllesa qualltyassurancesystem,which is subjectto periodicsurveillance,definedby Annex ll,
section5 of the aforementioneddirective.For placingon the marketof class lll devicescoveredby
certificateaccordingto Annex ll, section4 is required.
this certificatean EC design-examination
E f f e c t i v eD a t e :
Date:
2or2-a9-24
zar2-09-24
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Attachmentto
Certificate
RegistrationNo":
ReportNo.:
Manufacturer:
HD 60078931
0001
30791610
006
SterngoldDentalLLC
23 FrankMossbergDrive
Atileboro MA 02703
USA
FrcCucts:
Denta] Implent
Frodrjct.rj
nent-al P:-r:sthetic Froducts
$u:'gical.ly
Invasive
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riridi db23i-:41t Cao? Faxi 42547 83
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Date: 2012-09-24
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