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FDA 510(k)

BLUEWAND LED DENTAL CURING WAND SYSTEM

K-Number: K040614 · 2004-04-07

ApplicantJ.L. Blosser, Inc.
Decision Date2004-04-07
Product CodeEBZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BLUEWAND LED DENTAL CURING WAND SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is J.L. Blosser, Inc.. It received FDA 510(k) clearance on 2004-04-07 under 510(k) number K040614. 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 BLUEWAND LED DENTAL CURING WAND SYSTEM?

BLUEWAND LED DENTAL CURING WAND SYSTEM is a medical device that received FDA 510(k) clearance on 2004-04-07. The listed applicant is J.L. Blosser, Inc.. The 510(k) number is K040614.

When did BLUEWAND LED DENTAL CURING WAND SYSTEM receive FDA 510(k) clearance?

BLUEWAND LED DENTAL CURING WAND SYSTEM received FDA 510(k) clearance on 2004-04-07, under 510(k) number K040614.

Who is the listed applicant for BLUEWAND LED DENTAL CURING WAND SYSTEM?

The FDA 510(k) record lists J.L. Blosser, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BLUEWAND LED DENTAL CURING WAND SYSTEM?

The FDA product code for BLUEWAND LED DENTAL CURING WAND SYSTEM 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.

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Other records listing J.L. Blosser, 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.

K933459RESIMENT WITH FLUORIDE

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.

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