FDA · official record K203701Substantially Equivalent

Locator Overdenture Implant System

Name: Locator Overdenture Implant System — FDA K203701
Creator: Ivory Super Holdco Inc. / Zest Anchors, LLC
Keywords: Locator Overdenture Implant System, Locator Overdenture Implant System, K203701, DZE, FDA

United StatesDZEIvory Super Holdco Inc. / Zest Anchors, LLC

Verified

Official record identity

FDA application number: K203701
Decision date: April 15, 2021
Published decision: Substantially Equivalent

Classification

Product code: DZE

Published parties

Applicant: Ivory Super Holdco Inc. / Zest Anchors, LLC

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2020-12-18
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.3640

About this record

This record preserves an application published in the FDA 510(k) bulk export, including the DEN entries FDA includes in that export. Historical decisions do not establish current marketing status. Product-code harmonization is separate from the original application; joined establishment identifiers are not assigned to the applicant. The complete official export is checked daily and raw evidence is retained.