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FDA 510(k)

Light Cure Dental Adhesive

K-Number: K201787 · 2020-09-25

ApplicantRizhao Huge Biomaterials Company, Ltd.
Decision Date2020-09-25
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Light Cure Dental Adhesive is a medical device manufactured by Rizhao Huge Biomaterials Company, Ltd.. It received FDA 510(k) clearance on 2020-09-25 under approval number K201787. The device is classified under product code KLE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Light Cure Dental Adhesive?

Light Cure Dental Adhesive is a medical device that received FDA 510(k) clearance on 2020-09-25. It is manufactured by Rizhao Huge Biomaterials Company, Ltd.. The 510(k) number is K201787.

When was Light Cure Dental Adhesive approved by the FDA?

Light Cure Dental Adhesive received FDA 510(k) clearance on 2020-09-25, under approval number K201787.

What company makes Light Cure Dental Adhesive?

Light Cure Dental Adhesive is manufactured by Rizhao Huge Biomaterials Company, Ltd..

What is the FDA product code for Light Cure Dental Adhesive?

The FDA product code for Light Cure Dental Adhesive is KLE.

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Other Devices by Rizhao Huge Biomaterials Company, Ltd.

K201790Dual Cure Resin Cement K202063TrusFIL Universal Composite Restorative K221510TrusFIL-Flow Flowable Composite Restorative K221450Phosphoric Acid Etching Gel K233082TopCEM Dual Cure Resin Cement K230455Enamel Coating Resin

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Related Devices (Code: KLE)

K161891HC PrimerShofu Dental Corporation K161042CLEARFIL Universal Bond Quick Bottle Standard Kit, CLEARFIL Universal Bond Quick Bottle Refill, CLEARFIL Universal Bond Quick Bottle Value packKuraray Noritake Dental, Inc. K161051All-Bond Universal w/BAC (not finalized)Bisco, Inc. K171226TOKUYAMA UNIVERSAL BONDTokuyama Dental Corporation K172176Parkell Universal AdhesiveParkell, Inc. K172106SHOFU MZ Primer PlusShofu Dental Corporation

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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