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FDA 510(k)

PHOTAC-FIL APLICAP

K-Number: K925027 · 1993-06-18

ApplicantEspe GmbH (Us)
Decision Date1993-06-18
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PHOTAC-FIL APLICAP 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 1993-06-18 under 510(k) number K925027. 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 PHOTAC-FIL APLICAP?

PHOTAC-FIL APLICAP is a medical device that received FDA 510(k) clearance on 1993-06-18. The listed applicant is Espe GmbH (Us). The 510(k) number is K925027.

When did PHOTAC-FIL APLICAP receive FDA 510(k) clearance?

PHOTAC-FIL APLICAP received FDA 510(k) clearance on 1993-06-18, under 510(k) number K925027.

Who is the listed applicant for PHOTAC-FIL APLICAP?

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 PHOTAC-FIL APLICAP?

The FDA product code for PHOTAC-FIL APLICAP 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.

K913966SONO(R) -CEMK915005PHOTAC-BOND APLICAP, MODIFICATIONK913857ROCATEC(R) -PLUSK913965ESPE(R) -SILK905604VISIO-GEM ART-SYSTEMK904096PHOTAC-BOND

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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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