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FDA 510(k)

Noris Medical MBI-2mm Dental Implant System

K-Number: K162308 · 2017-03-17

Decision Date2017-03-17
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Noris Medical MBI-2mm Dental Implant System is the device name listed in this FDA 510(k) record. The listed applicant is Noris Medical , Ltd.. It received FDA 510(k) clearance on 2017-03-17 under 510(k) number K162308. 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 Noris Medical MBI-2mm Dental Implant System?

Noris Medical MBI-2mm Dental Implant System is a medical device that received FDA 510(k) clearance on 2017-03-17. The listed applicant is Noris Medical , Ltd.. The 510(k) number is K162308.

When did Noris Medical MBI-2mm Dental Implant System receive FDA 510(k) clearance?

Noris Medical MBI-2mm Dental Implant System received FDA 510(k) clearance on 2017-03-17, under 510(k) number K162308.

Who is the listed applicant for Noris Medical MBI-2mm Dental Implant System?

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

What is the FDA product code for Noris Medical MBI-2mm Dental Implant System?

The FDA product code for Noris Medical MBI-2mm Dental Implant System is DZE.

Other records listing Noris Medical , 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.

View all 7 devices →

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.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.