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FDA 510(k)

ESPE KETAC-ENDO APLICAP

K-Number: K911061 · 1992-01-03

ApplicantH.A. Opotow Consulting
Decision Date1992-01-03
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ESPE KETAC-ENDO APLICAP is the device name listed in this FDA 510(k) record. The listed applicant is H.A. Opotow Consulting. It received FDA 510(k) clearance on 1992-01-03 under 510(k) number K911061. 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 ESPE KETAC-ENDO APLICAP?

ESPE KETAC-ENDO APLICAP is a medical device that received FDA 510(k) clearance on 1992-01-03. The listed applicant is H.A. Opotow Consulting. The 510(k) number is K911061.

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

ESPE KETAC-ENDO APLICAP received FDA 510(k) clearance on 1992-01-03, under 510(k) number K911061.

Who is the listed applicant for ESPE KETAC-ENDO APLICAP?

The FDA 510(k) record lists H.A. Opotow Consulting as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ESPE KETAC-ENDO APLICAP?

The FDA product code for ESPE KETAC-ENDO APLICAP is EMA.

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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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