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FDA 510(k)

DOC'S BEST WHITE COPPER CEMENT

K-Number: K031494 · 2003-11-12

ApplicantCooley & Cooley, Ltd.
Decision Date2003-11-12
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DOC'S BEST WHITE COPPER CEMENT is the device name listed in this FDA 510(k) record. The listed applicant is Cooley & Cooley, Ltd.. It received FDA 510(k) clearance on 2003-11-12 under 510(k) number K031494. 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 DOC'S BEST WHITE COPPER CEMENT?

DOC'S BEST WHITE COPPER CEMENT is a medical device that received FDA 510(k) clearance on 2003-11-12. The listed applicant is Cooley & Cooley, Ltd.. The 510(k) number is K031494.

When did DOC'S BEST WHITE COPPER CEMENT receive FDA 510(k) clearance?

DOC'S BEST WHITE COPPER CEMENT received FDA 510(k) clearance on 2003-11-12, under 510(k) number K031494.

Who is the listed applicant for DOC'S BEST WHITE COPPER CEMENT?

The FDA 510(k) record lists Cooley & Cooley, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DOC'S BEST WHITE COPPER CEMENT?

The FDA product code for DOC'S BEST WHITE COPPER CEMENT 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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