Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

REIGNING ARTIFICIAL TEETH

K-Number: K802492 · 1980-11-12

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

Device Summary

REIGNING ARTIFICIAL TEETH 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 K802492. The device is classified under product code ELM. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REIGNING ARTIFICIAL TEETH?

REIGNING ARTIFICIAL TEETH 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 K802492.

When did REIGNING ARTIFICIAL TEETH receive FDA 510(k) clearance?

REIGNING ARTIFICIAL TEETH received FDA 510(k) clearance on 1980-11-12, under 510(k) number K802492.

Who is the listed applicant for REIGNING ARTIFICIAL TEETH?

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 ARTIFICIAL TEETH?

The FDA product code for REIGNING ARTIFICIAL TEETH is ELM.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 BRIDGEK802491REIGNING REPAIR EPOXY RESINK801236REIGNING EPOXY RESIN CEMENTK801235REIGNING ARTIFICIAL TEETH/POLYCARB.RESIN

View all 9 devices →

Related Devices (Code: ELM)

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.

K122955DENTAVIT, MONARCH, ACROTONE, SENATOR, DENTORIUMWright Health Group , Ltd.K122925NEW STETIC ARTIFICIAL TEETHNew SteticK122852PHYSIOSTAR NFCCandulor USA, Inc.K121749VERACIAShofu Dental CorporationK120404MERZ DENTAL GMBH ARTEGRAL HD PREFORMED PLASTIC DENTURE TEETHMerz Dental GmbHK120736SR PHONARES IIIvoclar Vivadent, AG

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.

↑