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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 a medical device manufactured by Ziacom Medical, S.L.. It received FDA 510(k) clearance on 2019-07-18 under approval 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. It is manufactured by Ziacom Medical, S.L.. The 510(k) number is K182908.

When was Ziacom Dental Implant Systems approved by the FDA?

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

What company makes Ziacom Dental Implant Systems?

Ziacom Dental Implant Systems is manufactured by Ziacom Medical, S.L..

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

NCT07608302 Comparison of the Predictability of Dentoalveolar Expansion With Two Clear Aligner Systems COMPLETED NCT07605286 Soft Tissue Augmentation Around Dental Implants COMPLETED NCT07589140 Influence of Alveolar Bone Drilling and Anatomical Position on Integration NOT_YET_RECRUITING NCT07246499 Multicentre Study on the Impact of Transmucosal Abutment Surface Characteristics on Peri-implant Tissues. ACTIVE_NOT_RECRUITING NCT07586163 Effectiveness of Clear Aligner Systems in Mixed Dentition Maxillary Transverse Deficiency ACTIVE_NOT_RECRUITING NCT07240493 BMP Effect on Implant Stability and Marginal Bone Level After Immediate Placement COMPLETED

Related PubMed Literature

PMID: 40774046 Strengthening Dental Materiovigilance: A Review of International Reporting Frameworks. International dental journal (2025)

Related Devices (Code: DZE)

K160475Ritter Dental Implant SystemRitter Implants GmbH & Co. KG K161244s-Clean OneQ-SL Narrow Implant SystemDentis Co., Ltd. K163043Zeramex P6 Dental Implant SystemDentalpoint AG K161497Dental Implants and AbutmentsDitron Precision, Ltd. K153332ETIII SA Fixture System (O3.2mm)Hiossen, Inc. K151970KJ Mini Implant SystemKj Meditech Co., Ltd.

Official Source

View on FDA Database →

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

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