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FDA 510(k)

REIGNING CROWN-BRIDGE/POLYCARB. RESIN

K-Number: K801237 · 1980-06-09

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

Device Summary

REIGNING CROWN-BRIDGE/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 K801237. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REIGNING CROWN-BRIDGE/POLYCARB. RESIN?

REIGNING CROWN-BRIDGE/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 K801237.

When did REIGNING CROWN-BRIDGE/POLYCARB. RESIN receive FDA 510(k) clearance?

REIGNING CROWN-BRIDGE/POLYCARB. RESIN received FDA 510(k) clearance on 1980-06-09, under 510(k) number K801237.

Who is the listed applicant for REIGNING CROWN-BRIDGE/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 CROWN-BRIDGE/POLYCARB. RESIN?

The FDA product code for REIGNING CROWN-BRIDGE/POLYCARB. RESIN is EBF.

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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: EBF)

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.

K262982Core·it DualSpident Co., Ltd.K262202Cerasmart ForteGC America, Inc.K261695Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF)Guilin Kevin Peter Technology Co., Ltd.K261485Tetric plus Fill;Tetric plus FlowIvoclar Vivadent, Inc.K262228Transcend Bulk Fill Flowable CompositeUltradent Products, Inc.K261246SRGC-06GC America, 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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