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FDA 510(k)

REIGNING DENTURE MADE OF POLYCARB. RESIN

K-Number: K801234 · 1980-06-09

ApplicantOki Shiks USA , Ltd.
Decision Date1980-06-09
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

REIGNING DENTURE MADE OF POLYCARB. 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 1980-06-09 under 510(k) number K801234. 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 DENTURE MADE OF POLYCARB. RESIN?

REIGNING DENTURE MADE OF POLYCARB. RESIN is a medical device that received FDA 510(k) clearance on 1980-06-09. The listed applicant is Oki Shiks USA , Ltd.. The 510(k) number is K801234.

When did REIGNING DENTURE MADE OF POLYCARB. RESIN receive FDA 510(k) clearance?

REIGNING DENTURE MADE OF POLYCARB. RESIN received FDA 510(k) clearance on 1980-06-09, under 510(k) number K801234.

Who is the listed applicant for REIGNING DENTURE MADE OF POLYCARB. 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 DENTURE MADE OF POLYCARB. RESIN?

The FDA product code for REIGNING DENTURE MADE OF POLYCARB. RESIN is EBI.

Related Clinical Trials

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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 RESINK801236REIGNING EPOXY RESIN CEMENT

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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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