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)

DURODENT CORPORATION ARTIFICIAL PLASTIC TEETH

K-Number: K933737 · 1994-06-13

ApplicantDurodent Corp.
Decision Date1994-06-13
Product CodeELM
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DURODENT CORPORATION ARTIFICIAL PLASTIC TEETH is the device name listed in this FDA 510(k) record. The listed applicant is Durodent Corp.. It received FDA 510(k) clearance on 1994-06-13 under 510(k) number K933737. 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 DURODENT CORPORATION ARTIFICIAL PLASTIC TEETH?

DURODENT CORPORATION ARTIFICIAL PLASTIC TEETH is a medical device that received FDA 510(k) clearance on 1994-06-13. The listed applicant is Durodent Corp.. The 510(k) number is K933737.

When did DURODENT CORPORATION ARTIFICIAL PLASTIC TEETH receive FDA 510(k) clearance?

DURODENT CORPORATION ARTIFICIAL PLASTIC TEETH received FDA 510(k) clearance on 1994-06-13, under 510(k) number K933737.

Who is the listed applicant for DURODENT CORPORATION ARTIFICIAL PLASTIC TEETH?

The FDA 510(k) record lists Durodent Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DURODENT CORPORATION ARTIFICIAL PLASTIC TEETH?

The FDA product code for DURODENT CORPORATION ARTIFICIAL PLASTIC 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

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.

↑