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)

COOLBLU CURING LIGHT

K-Number: K002925 · 2000-12-20

ApplicantDental Systems.Com, Inc.
Decision Date2000-12-20
Product CodeEBZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

COOLBLU CURING LIGHT is the device name listed in this FDA 510(k) record. The listed applicant is Dental Systems.Com, Inc.. It received FDA 510(k) clearance on 2000-12-20 under 510(k) number K002925. 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 COOLBLU CURING LIGHT?

COOLBLU CURING LIGHT is a medical device that received FDA 510(k) clearance on 2000-12-20. The listed applicant is Dental Systems.Com, Inc.. The 510(k) number is K002925.

When did COOLBLU CURING LIGHT receive FDA 510(k) clearance?

COOLBLU CURING LIGHT received FDA 510(k) clearance on 2000-12-20, under 510(k) number K002925.

Who is the listed applicant for COOLBLU CURING LIGHT?

The FDA 510(k) record lists Dental Systems.Com, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COOLBLU CURING LIGHT?

The FDA product code for COOLBLU 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 Dental Systems.Com, Inc. 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.

K020171COOLBLU2 DENTAL RESIN CURING DEVICE

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.

↑