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FDA 510(k)

PROTEMP 3 GARANT

K-Number: K033022 · 2003-11-21

Applicant3M Espe AG Dental Products
Decision Date2003-11-21
Product CodeEBG
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PROTEMP 3 GARANT 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 2003-11-21 under 510(k) number K033022. 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 PROTEMP 3 GARANT?

PROTEMP 3 GARANT is a medical device that received FDA 510(k) clearance on 2003-11-21. The listed applicant is 3M Espe AG Dental Products. The 510(k) number is K033022.

When did PROTEMP 3 GARANT receive FDA 510(k) clearance?

PROTEMP 3 GARANT received FDA 510(k) clearance on 2003-11-21, under 510(k) number K033022.

Who is the listed applicant for PROTEMP 3 GARANT?

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 PROTEMP 3 GARANT?

The FDA product code for PROTEMP 3 GARANT is EBG.

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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

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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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