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FDA 510(k)

DYRACT CEM LCI COMPOMER

K-Number: K003921 · 2001-01-24

ApplicantDentsply Intl.
Decision Date2001-01-24
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DYRACT CEM LCI COMPOMER is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Intl.. It received FDA 510(k) clearance on 2001-01-24 under 510(k) number K003921. 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 DYRACT CEM LCI COMPOMER?

DYRACT CEM LCI COMPOMER is a medical device that received FDA 510(k) clearance on 2001-01-24. The listed applicant is Dentsply Intl.. The 510(k) number is K003921.

When did DYRACT CEM LCI COMPOMER receive FDA 510(k) clearance?

DYRACT CEM LCI COMPOMER received FDA 510(k) clearance on 2001-01-24, under 510(k) number K003921.

Who is the listed applicant for DYRACT CEM LCI COMPOMER?

The FDA 510(k) record lists Dentsply Intl. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DYRACT CEM LCI COMPOMER?

The FDA product code for DYRACT CEM LCI COMPOMER 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

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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