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FDA 510(k)

REIGNING EPOXY RESIN CEMENT

K-Number: K801236 · 1980-07-08

ApplicantOki Shiks USA , Ltd.
Decision Date1980-07-08
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

REIGNING EPOXY RESIN CEMENT is the device name listed in this FDA 510(k) record. The listed applicant is Oki Shiks USA , Ltd.. It received FDA 510(k) clearance on 1980-07-08 under 510(k) number K801236. 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 REIGNING EPOXY RESIN CEMENT?

REIGNING EPOXY RESIN CEMENT is a medical device that received FDA 510(k) clearance on 1980-07-08. The listed applicant is Oki Shiks USA , Ltd.. The 510(k) number is K801236.

When did REIGNING EPOXY RESIN CEMENT receive FDA 510(k) clearance?

REIGNING EPOXY RESIN CEMENT received FDA 510(k) clearance on 1980-07-08, under 510(k) number K801236.

Who is the listed applicant for REIGNING EPOXY RESIN CEMENT?

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

What is the FDA product code for REIGNING EPOXY RESIN CEMENT?

The FDA product code for REIGNING EPOXY RESIN CEMENT is EMA.

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Other records listing Oki Shiks USA , Ltd. 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.

K821217REIGNING DENTUREK802490REIGNING DENTUREK802489REIGNING CROWN BRIDGEK802492REIGNING ARTIFICIAL TEETHK802491REIGNING REPAIR EPOXY RESINK801235REIGNING ARTIFICIAL TEETH/POLYCARB.RESIN

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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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