Dental Implant Abutment OKTAGON Bone Level RC, Dental Implant Abutment OKTAGON Bone Level NC

Abutment, Implant, Dental, Endosseous

HAGER & MEISINGER GMBH

The following data is part of a premarket notification filed by Hager & Meisinger Gmbh with the FDA for Dental Implant Abutment Oktagon Bone Level Rc, Dental Implant Abutment Oktagon Bone Level Nc.

Pre-market Notification Details

Device IDK160132
510k NumberK160132
Device Name:Dental Implant Abutment OKTAGON Bone Level RC, Dental Implant Abutment OKTAGON Bone Level NC
ClassificationAbutment, Implant, Dental, Endosseous
Applicant HAGER & MEISINGER GMBH HANSEMANNSTRASSE 10 Neuss,  DE 41468
ContactMelanie May
CorrespondentMelanie May
HAGER & MEISINGER GMBH HANSEMANNSTRASSE 10 Neuss,  DE 41468
Product CodeNHA  
CFR Regulation Number872.3630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-01-20
Decision Date2016-11-21
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00614950026999 K160132 000
E0HM50220261 K160132 000
E0HM50221031 K160132 000
E0HM50221051 K160132 000
00614950026920 K160132 000
00614950026937 K160132 000
00614950026944 K160132 000
00614950026951 K160132 000
00614950026968 K160132 000
00614950026975 K160132 000
00614950026982 K160132 000
E0HM50220251 K160132 000

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