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FDA 510(k)

SAPPHIRE PLASMA ARC DENTAL CURING LIGHT

K-Number: K081287 · 2008-11-21

ApplicantDen-Mat Holdings, LLC
Decision Date2008-11-21
Product CodeEBZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SAPPHIRE PLASMA ARC DENTAL CURING LIGHT is the device name listed in this FDA 510(k) record. The listed applicant is Den-Mat Holdings, LLC. It received FDA 510(k) clearance on 2008-11-21 under 510(k) number K081287. 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 SAPPHIRE PLASMA ARC DENTAL CURING LIGHT?

SAPPHIRE PLASMA ARC DENTAL CURING LIGHT is a medical device that received FDA 510(k) clearance on 2008-11-21. The listed applicant is Den-Mat Holdings, LLC. The 510(k) number is K081287.

When did SAPPHIRE PLASMA ARC DENTAL CURING LIGHT receive FDA 510(k) clearance?

SAPPHIRE PLASMA ARC DENTAL CURING LIGHT received FDA 510(k) clearance on 2008-11-21, under 510(k) number K081287.

Who is the listed applicant for SAPPHIRE PLASMA ARC DENTAL CURING LIGHT?

The FDA 510(k) record lists Den-Mat Holdings, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SAPPHIRE PLASMA ARC DENTAL CURING LIGHT?

The FDA product code for SAPPHIRE PLASMA ARC DENTAL CURING LIGHT is EBZ.

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Other records listing Den-Mat Holdings, LLC 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.

K262252MPa Max adhesiveK242097DenMat Bulk Fill CompositeK162967nuance UNIVERSALK110079SPPHINE PLUS STM 3W DIODE LASERK103667SAPPHIRE ST PORTABLE DIODE LASERK073483SAPPHIRE O/E ORAL EXAMINATION SYSTEM

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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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