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FDA 510(k)

Biomate Dental Implant System

K-Number: K170732 · 2018-10-26

ApplicantBiomate Medical Devices Technology Co., Ltd.
Decision Date2018-10-26
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Biomate Dental Implant System is a medical device manufactured by Biomate Medical Devices Technology Co., Ltd.. It received FDA 510(k) clearance on 2018-10-26 under approval number K170732. 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 Biomate Dental Implant System?

Biomate Dental Implant System is a medical device that received FDA 510(k) clearance on 2018-10-26. It is manufactured by Biomate Medical Devices Technology Co., Ltd.. The 510(k) number is K170732.

When was Biomate Dental Implant System approved by the FDA?

Biomate Dental Implant System received FDA 510(k) clearance on 2018-10-26, under approval number K170732.

What company makes Biomate Dental Implant System?

Biomate Dental Implant System is manufactured by Biomate Medical Devices Technology Co., Ltd..

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

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

Related Clinical Trials

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Related PubMed Literature

PMID: 41966145 From Registry to Reality: Opportunities to Enhance Post-market Surveillance of High-Risk Medical Devices Comment on "Quality and Utility of European Cardiovascular and Orthopaedic Registries for the Regulatory Evaluation of Medical Device Safety and Performance Across the Implant Lifecycle: A Systematic Review". International journal of health policy and management (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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