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FDA 510(k)

LUXATEMP/LUXATEMP SOLAR/INSTATEMP

K-Number: K013674 · 2002-01-24

ApplicantDmg USA, Inc.
Decision Date2002-01-24
Product CodeEBG
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

LUXATEMP/LUXATEMP SOLAR/INSTATEMP 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 2002-01-24 under 510(k) number K013674. 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 LUXATEMP/LUXATEMP SOLAR/INSTATEMP?

LUXATEMP/LUXATEMP SOLAR/INSTATEMP is a medical device that received FDA 510(k) clearance on 2002-01-24. The listed applicant is Dmg USA, Inc.. The 510(k) number is K013674.

When did LUXATEMP/LUXATEMP SOLAR/INSTATEMP receive FDA 510(k) clearance?

LUXATEMP/LUXATEMP SOLAR/INSTATEMP received FDA 510(k) clearance on 2002-01-24, under 510(k) number K013674.

Who is the listed applicant for LUXATEMP/LUXATEMP SOLAR/INSTATEMP?

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 LUXATEMP/LUXATEMP SOLAR/INSTATEMP?

The FDA product code for LUXATEMP/LUXATEMP SOLAR/INSTATEMP is EBG.

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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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