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FDA 510(k)

Ti-one 101 TS Dental Implant System

K-Number: K172821 · 2018-06-11

ApplicantHung Chun Bio-S Co., Ltd.
Decision Date2018-06-11
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Ti-one 101 TS Dental Implant System is a medical device manufactured by Hung Chun Bio-S Co., Ltd.. It received FDA 510(k) clearance on 2018-06-11 under approval number K172821. 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 Ti-one 101 TS Dental Implant System?

Ti-one 101 TS Dental Implant System is a medical device that received FDA 510(k) clearance on 2018-06-11. It is manufactured by Hung Chun Bio-S Co., Ltd.. The 510(k) number is K172821.

When was Ti-one 101 TS Dental Implant System approved by the FDA?

Ti-one 101 TS Dental Implant System received FDA 510(k) clearance on 2018-06-11, under approval number K172821.

What company makes Ti-one 101 TS Dental Implant System?

Ti-one 101 TS Dental Implant System is manufactured by Hung Chun Bio-S Co., Ltd..

What is the FDA product code for Ti-one 101 TS Dental Implant System?

The FDA product code for Ti-one 101 TS 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)

Other Devices by Hung Chun Bio-S Co., Ltd.

K151362HC Spinal System

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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