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FDA 510(k)

Noris Medical MBI Dental Implant System

K-Number: K153043 · 2016-04-11

Decision Date2016-04-11
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Noris Medical MBI 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 2016-04-11 under 510(k) number K153043. 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 Dental Implant System?

Noris Medical MBI Dental Implant System is a medical device that received FDA 510(k) clearance on 2016-04-11. The listed applicant is Noris Medical , Ltd.. The 510(k) number is K153043.

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

Noris Medical MBI Dental Implant System received FDA 510(k) clearance on 2016-04-11, under 510(k) number K153043.

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

The FDA product code for Noris Medical MBI 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.