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FDA 510(k)

IPS E.MAX CAD ABUTMENT SOLUTIONS

K-Number: K132209 · 2013-10-31

ApplicantIvoclar Vivadent, AG
Decision Date2013-10-31
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

IPS E.MAX CAD ABUTMENT SOLUTIONS is the device name listed in this FDA 510(k) record. The listed applicant is Ivoclar Vivadent, AG. It received FDA 510(k) clearance on 2013-10-31 under 510(k) number K132209. 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 IPS E.MAX CAD ABUTMENT SOLUTIONS?

IPS E.MAX CAD ABUTMENT SOLUTIONS is a medical device that received FDA 510(k) clearance on 2013-10-31. The listed applicant is Ivoclar Vivadent, AG. The 510(k) number is K132209.

When did IPS E.MAX CAD ABUTMENT SOLUTIONS receive FDA 510(k) clearance?

IPS E.MAX CAD ABUTMENT SOLUTIONS received FDA 510(k) clearance on 2013-10-31, under 510(k) number K132209.

Who is the listed applicant for IPS E.MAX CAD ABUTMENT SOLUTIONS?

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

What is the FDA product code for IPS E.MAX CAD ABUTMENT SOLUTIONS?

The FDA product code for IPS E.MAX CAD ABUTMENT SOLUTIONS is NHA.

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Other records listing Ivoclar Vivadent, 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.

K210804Adhese Universal DC, Cention PrimerK211916IPS e.max OneK193193Telio CAD Abutment Solutions- extra systemsK191453Cervitec FK191448Barrier SleevesK191382IPS e.max CAD Abutment Solutions- extra systems

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Related Devices (Code: NHA)

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K262207Cemented Plus AbutmentUnidental Co., Ltd.K260940BellaTek BarsZimVie US Corp, LLCK253999Universal 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.

Official Source

View on FDA Database →

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

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