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FDA 510(k)

ESPE KETAC-CEM RADIOPAQUE

K-Number: K844846 · 1985-03-25

ApplicantEspe GmbH (Us)
Decision Date1985-03-25
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ESPE KETAC-CEM RADIOPAQUE is the device name listed in this FDA 510(k) record. The listed applicant is Espe GmbH (Us). It received FDA 510(k) clearance on 1985-03-25 under 510(k) number K844846. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ESPE KETAC-CEM RADIOPAQUE?

ESPE KETAC-CEM RADIOPAQUE is a medical device that received FDA 510(k) clearance on 1985-03-25. The listed applicant is Espe GmbH (Us). The 510(k) number is K844846.

When did ESPE KETAC-CEM RADIOPAQUE receive FDA 510(k) clearance?

ESPE KETAC-CEM RADIOPAQUE received FDA 510(k) clearance on 1985-03-25, under 510(k) number K844846.

Who is the listed applicant for ESPE KETAC-CEM RADIOPAQUE?

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

What is the FDA product code for ESPE KETAC-CEM RADIOPAQUE?

The FDA product code for ESPE KETAC-CEM RADIOPAQUE is EMA.

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Other records listing Espe GmbH (Us) 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.

K925027PHOTAC-FIL APLICAPK915005PHOTAC-BOND APLICAP, MODIFICATIONK913966SONO(R) -CEMK913857ROCATEC(R) -PLUSK913965ESPE(R) -SILK905604VISIO-GEM ART-SYSTEM

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Related Devices (Code: EMA)

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.

K262983EsTemp ImplantSpident Co., Ltd.K254201Any-CemMediclus Co., Ltd.K261937PacTemp Automix NEThe Belport Company Inc., DBA Gingi-PakK261166DIA-CEMDiaDent Group InternationalK254109G-CEM UNIVERSALGC America, Inc.K253337REGEN Bioactive CementInter-Med, Inc.

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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