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FDA 510(k)

NB Implant System

K-Number: K230725 · 2023-07-01

ApplicantArum Dentistry Co., Ltd.
Decision Date2023-07-01
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

NB Implant System is the device name listed in this FDA 510(k) record. The listed applicant is Arum Dentistry Co., Ltd.. It received FDA 510(k) clearance on 2023-07-01 under 510(k) number K230725. 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 NB Implant System?

NB Implant System is a medical device that received FDA 510(k) clearance on 2023-07-01. The listed applicant is Arum Dentistry Co., Ltd.. The 510(k) number is K230725.

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

NB Implant System received FDA 510(k) clearance on 2023-07-01, under 510(k) number K230725.

Who is the listed applicant for NB Implant System?

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

What is the FDA product code for NB Implant System?

The FDA product code for NB Implant System is DZE.

Other records listing Arum Dentistry Co., Ltd. as applicant

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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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