2014 InterActive/SwishActive System

Implant, Endosseous, Root-form

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 2014 Interactive/swishactive System.

Pre-market Notification Details

Device IDK143011
510k NumberK143011
Device Name:2014 InterActive/SwishActive System
ClassificationImplant, Endosseous, Root-form
Applicant Implant Direct Sybron Manufacturing LLC 3050 East Hillcrest Drive Thousand Oaks,  CA  91362
ContactDebleena Sinha
CorrespondentDebleena Sinha
Implant Direct Sybron Manufacturing LLC 3050 East Hillcrest Drive Thousand Oaks,  CA  91362
Product CodeDZE  
CFR Regulation Number872.3640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-10-20
Decision Date2015-07-16
Summary:summary

NIH GUDID Devices

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