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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 the device name listed in this FDA 510(k) record. The listed applicant is Hung Chun Bio-S Co., Ltd.. It received FDA 510(k) clearance on 2018-06-11 under 510(k) 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. The listed applicant is Hung Chun Bio-S Co., Ltd.. The 510(k) number is K172821.

When did Ti-one 101 TS Dental Implant System receive FDA 510(k) clearance?

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

Who is the listed applicant for Ti-one 101 TS Dental Implant System?

The FDA 510(k) record lists Hung Chun Bio-S Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Hung Chun Bio-S Co., 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.

K151362HC Spinal System

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

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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