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FDA 510(k)

IR Type Implant System

K-Number: K171185 · 2017-12-01

ApplicantBiotem Co., Ltd.
Decision Date2017-12-01
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

IR Type Implant System is the device name listed in this FDA 510(k) record. The listed applicant is Biotem Co., Ltd.. It received FDA 510(k) clearance on 2017-12-01 under 510(k) number K171185. 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 IR Type Implant System?

IR Type Implant System is a medical device that received FDA 510(k) clearance on 2017-12-01. The listed applicant is Biotem Co., Ltd.. The 510(k) number is K171185.

When did IR Type Implant System receive FDA 510(k) clearance?

IR Type Implant System received FDA 510(k) clearance on 2017-12-01, under 510(k) number K171185.

Who is the listed applicant for IR Type Implant System?

The FDA 510(k) record lists Biotem Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IR Type Implant System?

The FDA product code for IR Type Implant System is DZE.

Other records listing Biotem 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.

K222142BR SLA Type Implant SystemK222144IR SLA Type Implant SystemK190641AR_N SLA Type Implant SystemK171179BR Type Implant SystemK171297AR_N Type Implant 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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