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FDA 510(k)

Ziacom Dental Implant Systems

K-Number: K182908 · 2019-07-18

ApplicantZiacom Medical, S.L.
Decision Date2019-07-18
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Ziacom Dental Implant Systems is the device name listed in this FDA 510(k) record. The listed applicant is Ziacom Medical, S.L.. It received FDA 510(k) clearance on 2019-07-18 under 510(k) number K182908. 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 Ziacom Dental Implant Systems?

Ziacom Dental Implant Systems is a medical device that received FDA 510(k) clearance on 2019-07-18. The listed applicant is Ziacom Medical, S.L.. The 510(k) number is K182908.

When did Ziacom Dental Implant Systems receive FDA 510(k) clearance?

Ziacom Dental Implant Systems received FDA 510(k) clearance on 2019-07-18, under 510(k) number K182908.

Who is the listed applicant for Ziacom Dental Implant Systems?

The FDA 510(k) record lists Ziacom Medical, S.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ziacom Dental Implant Systems?

The FDA product code for Ziacom Dental Implant Systems 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.

NCT05859113Evaluation of Marginal Bone Loss and Associated Factors Around Ziacom Dental Implants With Different Prosthetic ConnectionACTIVE_NOT_RECRUITING

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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