NOBELACTIVE 8.5 MM & 18.0 MM

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 Nobelactive 8.5 Mm & 18.0 Mm.

Pre-market Notification Details

Device IDK083205
510k NumberK083205
Device Name:NOBELACTIVE 8.5 MM & 18.0 MM
ClassificationImplant, Endosseous, Root-form
Applicant NOBEL BIOCARE AB 22715 SAVI RANCH PKWY. Yorba Linda,  CA  92887
ContactHerbert Crane
CorrespondentHerbert Crane
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 Received2008-10-30
Decision Date2009-02-13
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07332747039849 K083205 000
07332747160246 K083205 000
07332747160253 K083205 000
07332747160260 K083205 000
07332747160277 K083205 000
07332747160284 K083205 000
07332747017922 K083205 000
07332747017939 K083205 000
07332747017946 K083205 000
07332747017953 K083205 000
07332747017960 K083205 000
07332747017977 K083205 000
07332747039719 K083205 000
07332747039726 K083205 000
07332747039771 K083205 000
07332747039788 K083205 000
07332747039832 K083205 000
07332747160239 K083205 000

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