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FDA 510(k)

TEMPXN28

K-Number: K073296 · 2008-01-09

Applicant3M Espe AG Dental Products
Decision Date2008-01-09
Product CodeEBG
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TEMPXN28 is the device name listed in this FDA 510(k) record. The listed applicant is 3M Espe AG Dental Products. It received FDA 510(k) clearance on 2008-01-09 under 510(k) number K073296. 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 TEMPXN28?

TEMPXN28 is a medical device that received FDA 510(k) clearance on 2008-01-09. The listed applicant is 3M Espe AG Dental Products. The 510(k) number is K073296.

When did TEMPXN28 receive FDA 510(k) clearance?

TEMPXN28 received FDA 510(k) clearance on 2008-01-09, under 510(k) number K073296.

Who is the listed applicant for TEMPXN28?

The FDA 510(k) record lists 3M Espe AG Dental Products as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TEMPXN28?

The FDA product code for TEMPXN28 is EBG.

Related Clinical Trials

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.

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Other records listing 3M Espe AG Dental Products 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.

K100908UNICEM HMK100756MALTAK094007UNICEMK093721COSP2K091826ELEGANTK090718BELLUS SHADING KIT

View all 24 devices →

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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