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FDA 510(k)

NUVENTUS NV.C™ Dental Implant System

K-Number: K233081 · 2024-11-15

ApplicantInfinitum Eta, Ltd.
Decision Date2024-11-15
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

NUVENTUS NV.C™ Dental Implant System is the device name listed in this FDA 510(k) record. The listed applicant is Infinitum Eta, Ltd.. It received FDA 510(k) clearance on 2024-11-15 under 510(k) number K233081. 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 NUVENTUS NV.C™ Dental Implant System?

NUVENTUS NV.C™ Dental Implant System is a medical device that received FDA 510(k) clearance on 2024-11-15. The listed applicant is Infinitum Eta, Ltd.. The 510(k) number is K233081.

When did NUVENTUS NV.C™ Dental Implant System receive FDA 510(k) clearance?

NUVENTUS NV.C™ Dental Implant System received FDA 510(k) clearance on 2024-11-15, under 510(k) number K233081.

Who is the listed applicant for NUVENTUS NV.C™ Dental Implant System?

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

What is the FDA product code for NUVENTUS NV.C™ Dental Implant System?

The FDA product code for NUVENTUS NV.C™ Dental Implant System is DZE.

Other records listing Infinitum Eta, 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.

K251220NUVENTUS NV.C™ Prosthetic ComponentsK243317NUVENTUS NV.C™ Surgical Cassette and Tray

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

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

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