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FDA 510(k)

KETAC-CHEM

K-Number: K812115 · 1981-08-31

ApplicantEspe-Premier Sales Co.
Decision Date1981-08-31
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

KETAC-CHEM is the device name listed in this FDA 510(k) record. The listed applicant is Espe-Premier Sales Co.. It received FDA 510(k) clearance on 1981-08-31 under 510(k) number K812115. 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-CHEM?

KETAC-CHEM is a medical device that received FDA 510(k) clearance on 1981-08-31. The listed applicant is Espe-Premier Sales Co.. The 510(k) number is K812115.

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

KETAC-CHEM received FDA 510(k) clearance on 1981-08-31, under 510(k) number K812115.

Who is the listed applicant for KETAC-CHEM?

The FDA 510(k) record lists Espe-Premier Sales Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KETAC-CHEM?

The FDA product code for KETAC-CHEM is EMA.

Related Clinical Trials

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.

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Other records listing Espe-Premier Sales Co. 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.

K812116PERMAGUMK812117PERMAGUM ADHESIVEK812119NIMETIC-DISPERSK812118NIMETIC POLISHING PASTEK811624VISIO-SEALK810265VISIO-BAND

View all 10 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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