Temporary Snap Abutment

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 Temporary Snap Abutment.

Pre-market Notification Details

Device IDK161435
510k NumberK161435
Device Name:Temporary Snap Abutment
ClassificationAbutment, Implant, Dental, Endosseous
Applicant Nobel Biocare AB BOX 5190, SE-402 26, Vastra Hamngatan 1 Goteborg,  SE Se-411 17
ContactCharlemagne Chua
CorrespondentCharlemagne Chua
Nobel Biocare USA LLC 22715 Savi Ranch Parkway Yorba Linda,  CA  92887
Product CodeNHA  
CFR Regulation Number872.3630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-05-24
Decision Date2016-11-22
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07332747115710 K161435 000
07332747115604 K161435 000
07332747115611 K161435 000
07332747115628 K161435 000
07332747115635 K161435 000
07332747115642 K161435 000
07332747115666 K161435 000
07332747115673 K161435 000
07332747115680 K161435 000
07332747115697 K161435 000
07332747115703 K161435 000
07332747113891 K161435 000

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