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FDA 510(k)

REIGNING REPAIR EPOXY RESIN

K-Number: K802491 · 1980-11-12

ApplicantOki Shiks USA , Ltd.
Decision Date1980-11-12
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

REIGNING REPAIR EPOXY RESIN 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 1980-11-12 under 510(k) number K802491. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REIGNING REPAIR EPOXY RESIN?

REIGNING REPAIR EPOXY RESIN is a medical device that received FDA 510(k) clearance on 1980-11-12. The listed applicant is Oki Shiks USA , Ltd.. The 510(k) number is K802491.

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

REIGNING REPAIR EPOXY RESIN received FDA 510(k) clearance on 1980-11-12, under 510(k) number K802491.

Who is the listed applicant for REIGNING REPAIR EPOXY RESIN?

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 REPAIR EPOXY RESIN?

The FDA product code for REIGNING REPAIR EPOXY RESIN is EBI.

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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 DENTUREK802492REIGNING ARTIFICIAL TEETHK802489REIGNING CROWN BRIDGEK801236REIGNING EPOXY RESIN CEMENTK801235REIGNING ARTIFICIAL TEETH/POLYCARB.RESIN

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Related Devices (Code: EBI)

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.

K261802Glidewell™ Denture Base ResinPrismatik Dentalcraft, Inc.K261626UltraPrint Flexible Denture UVGuangzhou Heygears IMC., Inc.K262681NanoCeram Resin3BFAB TEKNOLOJI A.S.K262300Denture Base Resin V2Formlabs Ohio, Inc.K261474DENTCA Tru FlexibleDentca, Inc.K260569DB 4000 High Impact Denture BaseCarbon, 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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