Custom Bars

Abutment, Implant, Dental, Endosseous

IMPLANT DIRECT SYBRON MANUFACTURING, LLC

The following data is part of a premarket notification filed by Implant Direct Sybron Manufacturing, Llc with the FDA for Custom Bars.

Pre-market Notification Details

Device IDK162633
510k NumberK162633
Device Name:Custom Bars
ClassificationAbutment, Implant, Dental, Endosseous
Applicant IMPLANT DIRECT SYBRON MANUFACTURING, LLC 3050 EAST HILLCREST DRIVE Thousand Oaks,  CA  91362
ContactReina Choi
CorrespondentReina Choi
IMPLANT DIRECT SYBRON MANUFACTURING, LLC 3050 EAST HILLCREST DRIVE Thousand Oaks,  CA  91362
Product CodeNHA  
CFR Regulation Number872.3630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-09-21
Decision Date2017-07-24
Summary:summary

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