NobelSpeedy Groovy

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 Nobelspeedy Groovy.

Pre-market Notification Details

Device IDK160119
510k NumberK160119
Device Name:NobelSpeedy Groovy
ClassificationImplant, Endosseous, Root-form
Applicant NOBEL BIOCARE AB VASTRA HAMNGATAN 1 Goteborg,  SE Se-411 17
ContactCharlemagne Chua
CorrespondentChalemagne Chua
NOBEL BIOCARE USA LLC 22715 SAVI RANCH PARKWAY Yorba Linda,  CA  92887
Product CodeDZE  
CFR Regulation Number872.3640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-01-19
Decision Date2016-06-02
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07332747086263 K160119 000
07332747086256 K160119 000
07332747086249 K160119 000
07332747161045 K160119 000
07332747161038 K160119 000
07332747161021 K160119 000

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