Locator Overdenture Implant System

Implant, Endosseous, Root-form

Ivory Super Holdco Inc. / Zest Anchors LLC

The following data is part of a premarket notification filed by Ivory Super Holdco Inc. / Zest Anchors Llc with the FDA for Locator Overdenture Implant System.

Pre-market Notification Details

Device IDK203701
510k NumberK203701
Device Name:Locator Overdenture Implant System
ClassificationImplant, Endosseous, Root-form
Applicant Ivory Super Holdco Inc. / Zest Anchors LLC 2875 Loker Avenue East Carlsbad,  CA  92010
ContactMarysa Loustalot
CorrespondentMarysa Loustalot
Ivory Super Holdco Inc. / Zest Anchors LLC 2875 Loker Avenue East Carlsbad,  CA  92010
Product CodeDZE  
CFR Regulation Number872.3640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-12-18
Decision Date2021-04-15

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