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FDA 510(k)

REIGNING CROWN BRIDGE

K-Number: K802489 · 1980-11-12

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

Device Summary

REIGNING CROWN BRIDGE 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 K802489. The device is classified under product code EBG. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REIGNING CROWN BRIDGE?

REIGNING CROWN BRIDGE 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 K802489.

When did REIGNING CROWN BRIDGE receive FDA 510(k) clearance?

REIGNING CROWN BRIDGE received FDA 510(k) clearance on 1980-11-12, under 510(k) number K802489.

Who is the listed applicant for REIGNING CROWN BRIDGE?

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 CROWN BRIDGE?

The FDA product code for REIGNING CROWN BRIDGE is EBG.

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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 TEETHK802491REIGNING REPAIR EPOXY RESINK801236REIGNING EPOXY RESIN CEMENTK801235REIGNING ARTIFICIAL TEETH/POLYCARB.RESIN

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Related Devices (Code: EBG)

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.

K261261Dura-ArchHangzhou SHINING3D Dental Technology Co., Ltd.K253380“FLNT Base” and “FLNT Temp”Liaoning Upcera Co., Ltd.K251271TempFIT Temporary Crown and Bridge ResinRizhao Huge Biomaterials Company, Ltd.K243370DentaTOOTHAsiga Pty, Ltd.K243621Evoblock, PerléonEvoden Indústria Comércio Importação E ExportaçãoK243951TEMP MASTER, PMMA-based dental resinTaiwan Dental Materials Co., Ltd.

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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