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FDA 510(k)

NUVENTUS NV.C™ Prosthetic Components

K-Number: K251220 · 2025-07-28

ApplicantInfinitum Eta, Ltd.
Decision Date2025-07-28
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

NUVENTUS NV.C™ Prosthetic Components 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 2025-07-28 under 510(k) number K251220. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NUVENTUS NV.C™ Prosthetic Components?

NUVENTUS NV.C™ Prosthetic Components is a medical device that received FDA 510(k) clearance on 2025-07-28. The listed applicant is Infinitum Eta, Ltd.. The 510(k) number is K251220.

When did NUVENTUS NV.C™ Prosthetic Components receive FDA 510(k) clearance?

NUVENTUS NV.C™ Prosthetic Components received FDA 510(k) clearance on 2025-07-28, under 510(k) number K251220.

Who is the listed applicant for NUVENTUS NV.C™ Prosthetic Components?

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™ Prosthetic Components?

The FDA product code for NUVENTUS NV.C™ Prosthetic Components is NHA.

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.

K243317NUVENTUS NV.C™ Surgical Cassette and TrayK233081NUVENTUS NV.C™ Dental Implant System

Related Devices (Code: NHA)

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.

K253999Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC; Temporary Abutment Engaging and Non-Engaging; Healing Abutment Conical Connection; Omnigrip Clinical Screw Titanium; Omnigrip Prosthetic ScrewNobel Biocare ABK261147Neodent Implant System - NeoConvert FitJJGC Indústria e Comércio de Materiais Dentários S.A.K261122MIST ICImagine Milling Technologies, LLCK260061BioHorizons CEREC Compatible Ti-BasesBioHorizons Implant Systems, Inc.K253922Neodent Scannable Healing AbutmentJJGC Indústria e Comércio de Materiais Dentários S.A.K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC

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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