THE GUIDED SURGERY CONCEPT

Implant, Endosseous, Root-form

NOBEL BIOCARE AB

The following data is part of a premarket notification filed by Nobel Biocare Ab with the FDA for The Guided Surgery Concept.

Pre-market Notification Details

Device IDK050393
510k NumberK050393
Device Name:THE GUIDED SURGERY CONCEPT
ClassificationImplant, Endosseous, Root-form
Applicant NOBEL BIOCARE AB 22715 SAVI RANCH PKWY. Yorba Linda,  CA  92887
ContactElizabeth J Mason
CorrespondentElizabeth J Mason
NOBEL BIOCARE AB 22715 SAVI RANCH PKWY. Yorba Linda,  CA  92887
Product CodeDZE  
CFR Regulation Number872.3640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-02-16
Decision Date2005-05-04
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07332747015195 K050393 000
07332747000474 K050393 000

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