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)

EASY CURING PEN-STYLE LED CURING LIGHT

K-Number: K063659 · 2007-04-30

ApplicantDent Corp. Research & Development
Decision Date2007-04-30
Product CodeEBZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

EASY CURING PEN-STYLE LED CURING LIGHT is the device name listed in this FDA 510(k) record. The listed applicant is Dent Corp. Research & Development. It received FDA 510(k) clearance on 2007-04-30 under 510(k) number K063659. The device is classified under product code EBZ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EASY CURING PEN-STYLE LED CURING LIGHT?

EASY CURING PEN-STYLE LED CURING LIGHT is a medical device that received FDA 510(k) clearance on 2007-04-30. The listed applicant is Dent Corp. Research & Development. The 510(k) number is K063659.

When did EASY CURING PEN-STYLE LED CURING LIGHT receive FDA 510(k) clearance?

EASY CURING PEN-STYLE LED CURING LIGHT received FDA 510(k) clearance on 2007-04-30, under 510(k) number K063659.

Who is the listed applicant for EASY CURING PEN-STYLE LED CURING LIGHT?

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

What is the FDA product code for EASY CURING PEN-STYLE LED CURING LIGHT?

The FDA product code for EASY CURING PEN-STYLE LED CURING LIGHT is EBZ.

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 Dent Corp. Research & Development 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.

K020206INTRAORAL CAMERA ME-15K992233APEX LOCATOR BINGO-1020

Related Devices (Code: EBZ)

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.

K253131Curing Light (M-Cure 6)Guangzhou Rebornendo Medical Instrument Co., Ltd.K253461Demi ProMeta Systems Co., Ltd.K242386BluemoonGenoss Co., Ltd.K243921LED Curing Lights (DB686 HALO)Foshan Coxo Medical Instrument Co., Ltd.K250009LED Curing Light (C01-X, C02-X)Premium Plus (Dongguan) LimitedK241238LOOP™ LED Curing Light System (CLK01)Garrison Dental Solutions, LLC

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.

↑