BRANEMARK SYSTEM ZYGOMATICUS FIXTURE SYSTEM

Implant, Endosseous, Root-form

NOBEL BIOCARE UAS INC

The following data is part of a premarket notification filed by Nobel Biocare Uas Inc with the FDA for Branemark System Zygomaticus Fixture System.

Pre-market Notification Details

Device IDK970499
510k NumberK970499
Device Name:BRANEMARK SYSTEM ZYGOMATICUS FIXTURE SYSTEM
ClassificationImplant, Endosseous, Root-form
Applicant NOBEL BIOCARE UAS INC 777 OAKMONT LANE, SUITE 100 Westmont,  IL  60559
ContactBesty A Brown
CorrespondentBesty A Brown
NOBEL BIOCARE UAS INC 777 OAKMONT LANE, SUITE 100 Westmont,  IL  60559
Product CodeDZE  
CFR Regulation Number872.3640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-02-10
Decision Date1997-10-16
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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07332747025217 K970499 000
07332747025224 K970499 000
07332747159318 K970499 000

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