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FDA 510(k)

CIMOFLUOR

K-Number: K023888 · 2003-03-05

ApplicantGlobal Dental Products, Inc.
Decision Date2003-03-05
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CIMOFLUOR is the device name listed in this FDA 510(k) record. The listed applicant is Global Dental Products, Inc.. It received FDA 510(k) clearance on 2003-03-05 under 510(k) number K023888. 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 CIMOFLUOR?

CIMOFLUOR is a medical device that received FDA 510(k) clearance on 2003-03-05. The listed applicant is Global Dental Products, Inc.. The 510(k) number is K023888.

When did CIMOFLUOR receive FDA 510(k) clearance?

CIMOFLUOR received FDA 510(k) clearance on 2003-03-05, under 510(k) number K023888.

Who is the listed applicant for CIMOFLUOR?

The FDA 510(k) record lists Global Dental Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CIMOFLUOR?

The FDA product code for CIMOFLUOR 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 Global Dental Products, Inc. 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.

K061735INFIBRA, MODEL 1200

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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