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FDA 510(k)

ESPETEMP (TEMP. CEMENT)

K-Number: K770923 · 1977-06-01

ApplicantEspe GmbH (Us)
Decision Date1977-06-01
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ESPETEMP (TEMP. CEMENT) 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 1977-06-01 under 510(k) number K770923. 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 ESPETEMP (TEMP. CEMENT)?

ESPETEMP (TEMP. CEMENT) is a medical device that received FDA 510(k) clearance on 1977-06-01. The listed applicant is Espe GmbH (Us). The 510(k) number is K770923.

When did ESPETEMP (TEMP. CEMENT) receive FDA 510(k) clearance?

ESPETEMP (TEMP. CEMENT) received FDA 510(k) clearance on 1977-06-01, under 510(k) number K770923.

Who is the listed applicant for ESPETEMP (TEMP. CEMENT)?

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 ESPETEMP (TEMP. CEMENT)?

The FDA product code for ESPETEMP (TEMP. CEMENT) is EMA.

Related Clinical Trials

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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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