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FDA 510(k)

VARIOunite

K-Number: K160244 · 2016-06-02

ApplicantThommen Medical AG
Decision Date2016-06-02
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

VARIOunite is the device name listed in this FDA 510(k) record. The listed applicant is Thommen Medical AG. It received FDA 510(k) clearance on 2016-06-02 under 510(k) number K160244. 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 VARIOunite?

VARIOunite is a medical device that received FDA 510(k) clearance on 2016-06-02. The listed applicant is Thommen Medical AG. The 510(k) number is K160244.

When did VARIOunite receive FDA 510(k) clearance?

VARIOunite received FDA 510(k) clearance on 2016-06-02, under 510(k) number K160244.

Who is the listed applicant for VARIOunite?

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

What is the FDA product code for VARIOunite?

The FDA product code for VARIOunite is NHA.

Other records listing Thommen Medical AG 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.

K171795Thommen Implant SystemK151984Thommen Milling Abutment for CAD/CAM

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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