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FDA 510(k)

EXCELLITE TURBO LIGHT CURE UNIT

K-Number: K020877 · 2002-06-12

ApplicantRolence Ent., Inc.
Decision Date2002-06-12
Product CodeEBZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

EXCELLITE TURBO LIGHT CURE UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Rolence Ent., Inc.. It received FDA 510(k) clearance on 2002-06-12 under 510(k) number K020877. 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 EXCELLITE TURBO LIGHT CURE UNIT?

EXCELLITE TURBO LIGHT CURE UNIT is a medical device that received FDA 510(k) clearance on 2002-06-12. The listed applicant is Rolence Ent., Inc.. The 510(k) number is K020877.

When did EXCELLITE TURBO LIGHT CURE UNIT receive FDA 510(k) clearance?

EXCELLITE TURBO LIGHT CURE UNIT received FDA 510(k) clearance on 2002-06-12, under 510(k) number K020877.

Who is the listed applicant for EXCELLITE TURBO LIGHT CURE UNIT?

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

What is the FDA product code for EXCELLITE TURBO LIGHT CURE UNIT?

The FDA product code for EXCELLITE TURBO LIGHT CURE UNIT 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 Rolence Ent., 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.

K093084ROLENCE DENTAL HIGH SPEED HANDPIECE, RHPK023545ULTRA-LITE 200E LIGHT CURE UNITK020884EXCELLITE LIGHT CURE UNITK020874ULTRA-LITE 5 TURBO LIGHT CURE UNIT

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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