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FDA 510(k)

INTRA LUX HEAD 3 LDSY

K-Number: K092446 · 2009-11-03

ApplicantKaltenbach & Voigt GmbH & Co.
Decision Date2009-11-03
Product CodeEFA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

INTRA LUX HEAD 3 LDSY is the device name listed in this FDA 510(k) record. The listed applicant is Kaltenbach & Voigt GmbH & Co.. It received FDA 510(k) clearance on 2009-11-03 under 510(k) number K092446. The device is classified under product code EFA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTRA LUX HEAD 3 LDSY?

INTRA LUX HEAD 3 LDSY is a medical device that received FDA 510(k) clearance on 2009-11-03. The listed applicant is Kaltenbach & Voigt GmbH & Co.. The 510(k) number is K092446.

When did INTRA LUX HEAD 3 LDSY receive FDA 510(k) clearance?

INTRA LUX HEAD 3 LDSY received FDA 510(k) clearance on 2009-11-03, under 510(k) number K092446.

Who is the listed applicant for INTRA LUX HEAD 3 LDSY?

The FDA 510(k) record lists Kaltenbach & Voigt GmbH & Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INTRA LUX HEAD 3 LDSY?

The FDA product code for INTRA LUX HEAD 3 LDSY is EFA.

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Other records listing Kaltenbach & Voigt GmbH & Co. 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.

K080677COMFORTRONIC 4894 AND COMFORTDRIVE 200XDA HANDPIECE

Related Devices (Code: EFA)

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.

K192809Dental HandpieceMicro-Nx Co., Ltd.K163239SMARTmaticKaltenbach & Voigt GmbHK101172RDT3 HANDPIECE HEAD MODEL RDT3Redent Nova, Ltd.K093894ANTHOGYR IMPULSION IMPLANTOLOGY CONTRA-ANGLEAnthogyrK090055LOW & HIGH SPEED KITDpm USA Corp.K092412STRONG IMPLANT HANDPIECESSaeshin Precision Co., Ltd.

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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