NOBELPROCERA OVERDENTURE BAR

Abutment, Implant, Dental, Endosseous

NOBEL BIOCARE USA, LLC

The following data is part of a premarket notification filed by Nobel Biocare Usa, Llc with the FDA for Nobelprocera Overdenture Bar.

Pre-market Notification Details

Device IDK132749
510k NumberK132749
Device Name:NOBELPROCERA OVERDENTURE BAR
ClassificationAbutment, Implant, Dental, Endosseous
Applicant NOBEL BIOCARE USA, LLC 22715 SAVI RANCH PKWY. Yorba Linda,  CA  92887
ContactPhuong Nguyen Son
CorrespondentPhuong Nguyen Son
NOBEL BIOCARE USA, LLC 22715 SAVI RANCH PKWY. Yorba Linda,  CA  92887
Product CodeNHA  
CFR Regulation Number872.3630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-09-03
Decision Date2014-07-24
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07332747080858 K132749 000
07332747079760 K132749 000
07332747079777 K132749 000
07332747079784 K132749 000
07332747079791 K132749 000
07332747080803 K132749 000
07332747080810 K132749 000
07332747080827 K132749 000
07332747080834 K132749 000
07332747080841 K132749 000
07332747079753 K132749 000

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