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FDA 510(k)

KETAC-CEM MAXICAP

K-Number: K897188 · 1990-03-27

ApplicantEspe GmbH (Us)
Decision Date1990-03-27
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

KETAC-CEM MAXICAP 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 1990-03-27 under 510(k) number K897188. 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 KETAC-CEM MAXICAP?

KETAC-CEM MAXICAP is a medical device that received FDA 510(k) clearance on 1990-03-27. The listed applicant is Espe GmbH (Us). The 510(k) number is K897188.

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

KETAC-CEM MAXICAP received FDA 510(k) clearance on 1990-03-27, under 510(k) number K897188.

Who is the listed applicant for KETAC-CEM MAXICAP?

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 KETAC-CEM MAXICAP?

The FDA product code for KETAC-CEM MAXICAP 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 APLICAPK913966SONO(R) -CEMK915005PHOTAC-BOND APLICAP, MODIFICATIONK913857ROCATEC(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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