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FDA 510(k)

MULTIPURPOSE RESIN CEMENT WITH FLUORIDE (MRCF)

K-Number: K940459 · 1994-04-29

ApplicantDentsply Intl.
Decision Date1994-04-29
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MULTIPURPOSE RESIN CEMENT WITH FLUORIDE (MRCF) is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Intl.. It received FDA 510(k) clearance on 1994-04-29 under 510(k) number K940459. 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 MULTIPURPOSE RESIN CEMENT WITH FLUORIDE (MRCF)?

MULTIPURPOSE RESIN CEMENT WITH FLUORIDE (MRCF) is a medical device that received FDA 510(k) clearance on 1994-04-29. The listed applicant is Dentsply Intl.. The 510(k) number is K940459.

When did MULTIPURPOSE RESIN CEMENT WITH FLUORIDE (MRCF) receive FDA 510(k) clearance?

MULTIPURPOSE RESIN CEMENT WITH FLUORIDE (MRCF) received FDA 510(k) clearance on 1994-04-29, under 510(k) number K940459.

Who is the listed applicant for MULTIPURPOSE RESIN CEMENT WITH FLUORIDE (MRCF)?

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 MULTIPURPOSE RESIN CEMENT WITH FLUORIDE (MRCF)?

The FDA product code for MULTIPURPOSE RESIN CEMENT WITH FLUORIDE (MRCF) 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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