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FDA 510(k)

HYCEM APLICAP

K-Number: K963737 · 1996-11-15

ApplicantEspe GmbH & Co. Kg.
Decision Date1996-11-15
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

HYCEM APLICAP is the device name listed in this FDA 510(k) record. The listed applicant is Espe GmbH & Co. Kg.. It received FDA 510(k) clearance on 1996-11-15 under 510(k) number K963737. 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 HYCEM APLICAP?

HYCEM APLICAP is a medical device that received FDA 510(k) clearance on 1996-11-15. The listed applicant is Espe GmbH & Co. Kg.. The 510(k) number is K963737.

When did HYCEM APLICAP receive FDA 510(k) clearance?

HYCEM APLICAP received FDA 510(k) clearance on 1996-11-15, under 510(k) number K963737.

Who is the listed applicant for HYCEM APLICAP?

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

What is the FDA product code for HYCEM APLICAP?

The FDA product code for HYCEM APLICAP is EMA.

Related Clinical Trials

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Other records listing Espe GmbH & Co. Kg. 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.

K974231POSITION PENTA, POSITION PENTA QUICKK973513SINFONY DENTIN, OPAQUE-DENTIN, ENAMEL, ENAMEL MODIFIER, TRANSPARENT OPAL,SINFONY MAGIC MODIFIERS, SINFONY OPAQUERK973262KETAC-FIL APLICAP PLUSK972892CAVIT-LCK963735COJET SYSTEMK962428EBS (ESPE BONDING SYSTEM)

View all 17 devices →

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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