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FDA 510(k)

COOLBLU2 DENTAL RESIN CURING DEVICE

K-Number: K020171 · 2002-01-29

ApplicantDental Systems.Com, Inc.
Decision Date2002-01-29
Product CodeEBZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

COOLBLU2 DENTAL RESIN CURING DEVICE 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 2002-01-29 under 510(k) number K020171. 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 COOLBLU2 DENTAL RESIN CURING DEVICE?

COOLBLU2 DENTAL RESIN CURING DEVICE is a medical device that received FDA 510(k) clearance on 2002-01-29. The listed applicant is Dental Systems.Com, Inc.. The 510(k) number is K020171.

When did COOLBLU2 DENTAL RESIN CURING DEVICE receive FDA 510(k) clearance?

COOLBLU2 DENTAL RESIN CURING DEVICE received FDA 510(k) clearance on 2002-01-29, under 510(k) number K020171.

Who is the listed applicant for COOLBLU2 DENTAL RESIN CURING DEVICE?

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 COOLBLU2 DENTAL RESIN CURING DEVICE?

The FDA product code for COOLBLU2 DENTAL RESIN CURING DEVICE 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.

K002925COOLBLU CURING LIGHT

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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