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FDA 510(k)

LUXAFORM PLUS

K-Number: K033227 · 2004-01-16

ApplicantDmg USA, Inc.
Decision Date2004-01-16
Product CodeEBG
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

LUXAFORM PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Dmg USA, Inc.. It received FDA 510(k) clearance on 2004-01-16 under 510(k) number K033227. The device is classified under product code EBG. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LUXAFORM PLUS?

LUXAFORM PLUS is a medical device that received FDA 510(k) clearance on 2004-01-16. The listed applicant is Dmg USA, Inc.. The 510(k) number is K033227.

When did LUXAFORM PLUS receive FDA 510(k) clearance?

LUXAFORM PLUS received FDA 510(k) clearance on 2004-01-16, under 510(k) number K033227.

Who is the listed applicant for LUXAFORM PLUS?

The FDA 510(k) record lists Dmg USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LUXAFORM PLUS?

The FDA product code for LUXAFORM PLUS is EBG.

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Other records listing Dmg USA, Inc. as applicant

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Related Devices (Code: EBG)

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.

K261261Dura-ArchHangzhou SHINING3D Dental Technology Co., Ltd.K253380“FLNT Base” and “FLNT Temp”Liaoning Upcera Co., Ltd.K251271TempFIT Temporary Crown and Bridge ResinRizhao Huge Biomaterials Company, Ltd.K243370DentaTOOTHAsiga Pty, Ltd.K243621Evoblock, PerléonEvoden Indústria Comércio Importação E ExportaçãoK243951TEMP MASTER, PMMA-based dental resinTaiwan Dental Materials 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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