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FDA 510(k)

OP II VISIBLE LIGHT CURING SYSTEM

K-Number: K854696 · 1986-03-26

ApplicantAlmore Intl., Inc.
Decision Date1986-03-26
Product CodeEBZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OP II VISIBLE LIGHT CURING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Almore Intl., Inc.. It received FDA 510(k) clearance on 1986-03-26 under 510(k) number K854696. 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 OP II VISIBLE LIGHT CURING SYSTEM?

OP II VISIBLE LIGHT CURING SYSTEM is a medical device that received FDA 510(k) clearance on 1986-03-26. The listed applicant is Almore Intl., Inc.. The 510(k) number is K854696.

When did OP II VISIBLE LIGHT CURING SYSTEM receive FDA 510(k) clearance?

OP II VISIBLE LIGHT CURING SYSTEM received FDA 510(k) clearance on 1986-03-26, under 510(k) number K854696.

Who is the listed applicant for OP II VISIBLE LIGHT CURING SYSTEM?

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

What is the FDA product code for OP II VISIBLE LIGHT CURING SYSTEM?

The FDA product code for OP II VISIBLE LIGHT CURING SYSTEM is EBZ.

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Other records listing Almore Intl., 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.

K862851ALMORE FACE MASKK854692MONARCH II BLEACHING INSTRUMENTK854690DIAMONDS BURS-COMPOSIT FINISHINGK854691DIAMOND BURS-HANDPIECEK854700EZ-ON TUBING CONDITIONER (LUBRICANT)K854701RETRACT-A-CORD

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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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