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FDA 510(k)

Locator Overdenture Implant System

K-Number: K203701 · 2021-04-15

ApplicantIvory Super Holdco Inc. / Zest Anchors, LLC
Decision Date2021-04-15
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Locator Overdenture Implant System is the device name listed in this FDA 510(k) record. The listed applicant is Ivory Super Holdco Inc. / Zest Anchors, LLC. It received FDA 510(k) clearance on 2021-04-15 under 510(k) number K203701. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Locator Overdenture Implant System?

Locator Overdenture Implant System is a medical device that received FDA 510(k) clearance on 2021-04-15. The listed applicant is Ivory Super Holdco Inc. / Zest Anchors, LLC. The 510(k) number is K203701.

When did Locator Overdenture Implant System receive FDA 510(k) clearance?

Locator Overdenture Implant System received FDA 510(k) clearance on 2021-04-15, under 510(k) number K203701.

Who is the listed applicant for Locator Overdenture Implant System?

The FDA 510(k) record lists Ivory Super Holdco Inc. / Zest Anchors, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Locator Overdenture Implant System?

The FDA product code for Locator Overdenture Implant System is DZE.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07536776Radiographic and Retention Evaluation Over Seven Years for Four Implant Retained OverdentureCOMPLETED

Related Devices (Code: DZE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251188UNIQA® Dental Implants SystemUniqa Dental, Ltd.K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.K250806Dental Implant SystemA.B. Dental Devices , Ltd.K260006INOSS SystemInosys, Inc.K252731Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental ImplantPromimic ABK252031Adin Long Dental Implant SystemAdin Dental Implant Systems , Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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