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FDA 510(k)

Thommen Milling Abutment for CAD/CAM

K-Number: K151984 · 2016-03-10

ApplicantThommen Medical AG
Decision Date2016-03-10
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Thommen Milling Abutment for CAD/CAM 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 2016-03-10 under 510(k) number K151984. 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 Thommen Milling Abutment for CAD/CAM?

Thommen Milling Abutment for CAD/CAM is a medical device that received FDA 510(k) clearance on 2016-03-10. The listed applicant is Thommen Medical AG. The 510(k) number is K151984.

When did Thommen Milling Abutment for CAD/CAM receive FDA 510(k) clearance?

Thommen Milling Abutment for CAD/CAM received FDA 510(k) clearance on 2016-03-10, under 510(k) number K151984.

Who is the listed applicant for Thommen Milling Abutment for CAD/CAM?

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 Thommen Milling Abutment for CAD/CAM?

The FDA product code for Thommen Milling Abutment for CAD/CAM is NHA.

Related Clinical Trials

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.

NCT07633574Additive vs Subtractive Manufacturing for Endocrown Fabrication: A 24-Month RCTNOT_YET_RECRUITINGNCT076337173-D Printed Resin Composite Versus Milled Resin Composite and Hybrid Ceramic Onlays: 2-Year Clinical Performance, Microtensile Bond Strength, Marginal and Internal AdaptationACTIVE_NOT_RECRUITING

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 SystemK160244VARIOunite

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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