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FDA 510(k)

PROTEMP H

K-Number: K002364 · 2000-08-10

ApplicantEspe Dental AG
Decision Date2000-08-10
Product CodeEBG
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PROTEMP H is the device name listed in this FDA 510(k) record. The listed applicant is Espe Dental AG. It received FDA 510(k) clearance on 2000-08-10 under 510(k) number K002364. 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 H?

PROTEMP H is a medical device that received FDA 510(k) clearance on 2000-08-10. The listed applicant is Espe Dental AG. The 510(k) number is K002364.

When did PROTEMP H receive FDA 510(k) clearance?

PROTEMP H received FDA 510(k) clearance on 2000-08-10, under 510(k) number K002364.

Who is the listed applicant for PROTEMP H?

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

What is the FDA product code for PROTEMP H?

The FDA product code for PROTEMP H is EBG.

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Other records listing Espe Dental AG 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.

K011394LAVA FRAME, LAVA FRAME SHADE, LAVA CERAMK011154ELIPAR FREELIGHTK002793KETAC CEM UK001494MODIFICATION TO PROMPT L-POPK000595DIMENSION PENTA LK000588DIMENSION GARANT L, DIMENSION GARANT L QUICK

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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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