GPS Angled Abutment

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 Gps Angled Abutment.

Pre-market Notification Details

Device IDK153509
510k NumberK153509
Device Name:GPS Angled Abutment
ClassificationAbutment, Implant, Dental, Endosseous
Applicant IMPLANT DIRECT SYBRON MANUFACTURING LLC 3050 EAST HILLCREST DRIVE Thousand Oaks,  CA  91362
ContactDebleena Sinha
CorrespondentRenee Bennett
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 Received2015-12-07
Decision Date2016-08-26
Summary:summary

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