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FDA 510(k)

KETAC-MOLAR APLICAP

K-Number: K960954 · 1996-05-16

ApplicantEspe GmbH & Co. Kg.
Decision Date1996-05-16
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

KETAC-MOLAR 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 1996-05-16 under 510(k) number K960954. 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-MOLAR APLICAP?

KETAC-MOLAR APLICAP is a medical device that received FDA 510(k) clearance on 1996-05-16. The listed applicant is Espe GmbH & Co. Kg.. The 510(k) number is K960954.

When did KETAC-MOLAR APLICAP receive FDA 510(k) clearance?

KETAC-MOLAR APLICAP received FDA 510(k) clearance on 1996-05-16, under 510(k) number K960954.

Who is the listed applicant for KETAC-MOLAR 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 KETAC-MOLAR APLICAP?

The FDA product code for KETAC-MOLAR APLICAP is EMA.

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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 SYSTEMK963737HYCEM APLICAP

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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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