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FDA 510(k)

SPI CUSTOMIZABLE GINGIVA FORMER

K-Number: K092248 · 2009-09-25

ApplicantThommen Medical AG
Decision Date2009-09-25
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SPI CUSTOMIZABLE GINGIVA FORMER 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 2009-09-25 under 510(k) number K092248. 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 CUSTOMIZABLE GINGIVA FORMER?

SPI CUSTOMIZABLE GINGIVA FORMER is a medical device that received FDA 510(k) clearance on 2009-09-25. The listed applicant is Thommen Medical AG. The 510(k) number is K092248.

When did SPI CUSTOMIZABLE GINGIVA FORMER receive FDA 510(k) clearance?

SPI CUSTOMIZABLE GINGIVA FORMER received FDA 510(k) clearance on 2009-09-25, under 510(k) number K092248.

Who is the listed applicant for SPI CUSTOMIZABLE GINGIVA FORMER?

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 CUSTOMIZABLE GINGIVA FORMER?

The FDA product code for SPI CUSTOMIZABLE GINGIVA FORMER 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/CAMK121334VARIOECOK111984SPI VARIO ANGLED ABUTMENTK102804SPI TITANIUM BASE FOR CAD/CAM

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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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