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FDA 510(k)

FLIPO XENON CURING LIGHT

K-Number: K994028 · 2000-01-12

ApplicantLokki
Decision Date2000-01-12
Product CodeEBZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

FLIPO XENON CURING LIGHT is the device name listed in this FDA 510(k) record. The listed applicant is Lokki. It received FDA 510(k) clearance on 2000-01-12 under 510(k) number K994028. 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 FLIPO XENON CURING LIGHT?

FLIPO XENON CURING LIGHT is a medical device that received FDA 510(k) clearance on 2000-01-12. The listed applicant is Lokki. The 510(k) number is K994028.

When did FLIPO XENON CURING LIGHT receive FDA 510(k) clearance?

FLIPO XENON CURING LIGHT received FDA 510(k) clearance on 2000-01-12, under 510(k) number K994028.

Who is the listed applicant for FLIPO XENON CURING LIGHT?

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

What is the FDA product code for FLIPO XENON CURING LIGHT?

The FDA product code for FLIPO XENON CURING LIGHT 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 Lokki 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.

K952682LOKKI DT

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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