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FDA 510(k)

SMARTLITE PS PEN-STYLE LED CURING LIGHT

K-Number: K041372 · 2004-06-24

ApplicantDentsply International
Decision Date2004-06-24
Product CodeEBZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SMARTLITE PS PEN-STYLE LED CURING LIGHT is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply International. It received FDA 510(k) clearance on 2004-06-24 under 510(k) number K041372. 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 SMARTLITE PS PEN-STYLE LED CURING LIGHT?

SMARTLITE PS PEN-STYLE LED CURING LIGHT is a medical device that received FDA 510(k) clearance on 2004-06-24. The listed applicant is Dentsply International. The 510(k) number is K041372.

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

SMARTLITE PS PEN-STYLE LED CURING LIGHT received FDA 510(k) clearance on 2004-06-24, under 510(k) number K041372.

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

The FDA 510(k) record lists Dentsply International as the applicant. This does not by itself establish the device manufacturer.

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

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

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Other records listing Dentsply International as applicant

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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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