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FDA 510(k)

SPI VARIO ANGLED ABUTMENT

K-Number: K111984 · 2011-11-10

ApplicantThommen Medical AG
Decision Date2011-11-10
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SPI VARIO ANGLED ABUTMENT 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 2011-11-10 under 510(k) number K111984. 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 SPI VARIO ANGLED ABUTMENT?

SPI VARIO ANGLED ABUTMENT is a medical device that received FDA 510(k) clearance on 2011-11-10. The listed applicant is Thommen Medical AG. The 510(k) number is K111984.

When did SPI VARIO ANGLED ABUTMENT receive FDA 510(k) clearance?

SPI VARIO ANGLED ABUTMENT received FDA 510(k) clearance on 2011-11-10, under 510(k) number K111984.

Who is the listed applicant for SPI VARIO ANGLED ABUTMENT?

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 SPI VARIO ANGLED ABUTMENT?

The FDA product code for SPI VARIO ANGLED ABUTMENT is NHA.

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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 SystemK160244VARIOuniteK151984Thommen Milling Abutment for CAD/CAMK121334VARIOECOK102804SPI TITANIUM BASE FOR CAD/CAMK101798SPI VARIOMULTI ANGLED ABUTMENT

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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.

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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