BIODENTA DENTAL IMPLANT SYSTEM - ABUTMENTS

Abutment, Implant, Dental, Endosseous

BIODENTA SWISS AG

The following data is part of a premarket notification filed by Biodenta Swiss Ag with the FDA for Biodenta Dental Implant System - Abutments.

Pre-market Notification Details

Device IDK122559
510k NumberK122559
Device Name:BIODENTA DENTAL IMPLANT SYSTEM - ABUTMENTS
ClassificationAbutment, Implant, Dental, Endosseous
Applicant BIODENTA SWISS AG TRAMSTRASSE 16 Berneck,  CH 9442
ContactDavid Eiler
CorrespondentDavid Eiler
BIODENTA SWISS AG TRAMSTRASSE 16 Berneck,  CH 9442
Product CodeNHA  
CFR Regulation Number872.3630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-08-22
Decision Date2013-05-03
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07640169733802 K122559 000
07640169733796 K122559 000
07640169733789 K122559 000
07640169733772 K122559 000
07640169733765 K122559 000
07640169733758 K122559 000

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