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FDA 510(k)

DSI Dental Implant System

K-Number: K200188 · 2020-04-01

ApplicantDsi Dental Solutions, Ltd.
Decision Date2020-04-01
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DSI Dental Implant System is the device name listed in this FDA 510(k) record. The listed applicant is Dsi Dental Solutions, Ltd.. It received FDA 510(k) clearance on 2020-04-01 under 510(k) number K200188. 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 DSI Dental Implant System?

DSI Dental Implant System is a medical device that received FDA 510(k) clearance on 2020-04-01. The listed applicant is Dsi Dental Solutions, Ltd.. The 510(k) number is K200188.

When did DSI Dental Implant System receive FDA 510(k) clearance?

DSI Dental Implant System received FDA 510(k) clearance on 2020-04-01, under 510(k) number K200188.

Who is the listed applicant for DSI Dental Implant System?

The FDA 510(k) record lists Dsi Dental Solutions, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DSI Dental Implant System?

The FDA product code for DSI Dental Implant System is DZE.

Other records listing Dsi Dental Solutions, Ltd. as applicant

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.

K250778Sil-Flow

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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