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FDA 510(k)

ArgenIS Titanium Abutments

K-Number: K160248 · 2016-08-05

ApplicantArgen Corporation
Decision Date2016-08-05
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ArgenIS Titanium Abutments is the device name listed in this FDA 510(k) record. The listed applicant is Argen Corporation. It received FDA 510(k) clearance on 2016-08-05 under 510(k) number K160248. 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 ArgenIS Titanium Abutments?

ArgenIS Titanium Abutments is a medical device that received FDA 510(k) clearance on 2016-08-05. The listed applicant is Argen Corporation. The 510(k) number is K160248.

When did ArgenIS Titanium Abutments receive FDA 510(k) clearance?

ArgenIS Titanium Abutments received FDA 510(k) clearance on 2016-08-05, under 510(k) number K160248.

Who is the listed applicant for ArgenIS Titanium Abutments?

The FDA 510(k) record lists Argen Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ArgenIS Titanium Abutments?

The FDA product code for ArgenIS Titanium Abutments is NHA.

Other records listing Argen Corporation 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.

K242458ArgenZ MTZK192846Argen Clear Aligner, Argen Clear Aligner PremiumK183229Argen Clear AlignerK172430ArgenIS Titanium Abutments

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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