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)

LED Curing Light

K-Number: K220826 · 2022-12-08

ApplicantFoshan Coxo Medical Instrument Co., Ltd.
Decision Date2022-12-08
Product CodeEBZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

LED Curing Light is the device name listed in this FDA 510(k) record. The listed applicant is Foshan Coxo Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2022-12-08 under 510(k) number K220826. 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 LED Curing Light?

LED Curing Light is a medical device that received FDA 510(k) clearance on 2022-12-08. The listed applicant is Foshan Coxo Medical Instrument Co., Ltd.. The 510(k) number is K220826.

When did LED Curing Light receive FDA 510(k) clearance?

LED Curing Light received FDA 510(k) clearance on 2022-12-08, under 510(k) number K220826.

Who is the listed applicant for LED Curing Light?

The FDA 510(k) record lists Foshan Coxo Medical Instrument Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LED Curing Light?

The FDA product code for LED Curing Light is EBZ.

Other records listing Foshan Coxo Medical Instrument Co., 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.

K243921LED Curing Lights (DB686 HALO)K220179High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle Handpieces/Air MotorsK220829Endo MotorK222096Endo Ultrasonic ActivatorK220831Dental Implantation Systems, Dental Electrical MotorsK212178Root Apex Locator

View all 7 devices →

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.

↑