NOBELPROCERA PEEK ABUTMENTS

Abutment, Implant, Dental, Endosseous

NOBEL BIOCARE AB

The following data is part of a premarket notification filed by Nobel Biocare Ab with the FDA for Nobelprocera Peek Abutments.

Pre-market Notification Details

Device IDK120954
510k NumberK120954
Device Name:NOBELPROCERA PEEK ABUTMENTS
ClassificationAbutment, Implant, Dental, Endosseous
Applicant NOBEL BIOCARE AB 22715 SAVI RANCH PKWY. Yorba Linda,  CA  92887
ContactPhuong Nguyen Son
CorrespondentPhuong Nguyen Son
NOBEL BIOCARE AB 22715 SAVI RANCH PKWY. Yorba Linda,  CA  92887
Product CodeNHA  
CFR Regulation Number872.3630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-03-30
Decision Date2013-06-05
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07332747014204 K120954 000
07332747014198 K120954 000
07332747014181 K120954 000
07332747014143 K120954 000
07332747009279 K120954 000
07332747009262 K120954 000
07332747009255 K120954 000
07332747009248 K120954 000

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