Legacy2, Legacy3, Legacy4, SimplyLegacy2, SimplyLegacy3 Dental Implants; Legacy2, Legacy3, Legacy4 Fixture-mounts

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 Legacy2, Legacy3, Legacy4, Simplylegacy2, Simplylegacy3 Dental Implants; Legacy2, Legacy3, Legacy4 Fixture-mounts.

Pre-market Notification Details

Device IDK192221
510k NumberK192221
Device Name:Legacy2, Legacy3, Legacy4, SimplyLegacy2, SimplyLegacy3 Dental Implants; Legacy2, Legacy3, Legacy4 Fixture-mounts
ClassificationImplant, Endosseous, Root-form
Applicant Implant Direct Sybron Manufacturing, LLC 3050 East Hillcrest Drive Thousand Oaks,  CA  91362
ContactReina Choi
CorrespondentKelliann Payne
Hogan & Lovells US LPP 1735 Market Street Floor 23 Philadelphia,  PA  19103
Product CodeDZE  
CFR Regulation Number872.3640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-08-15
Decision Date2020-06-25

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