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FDA 510(k)

TopCEM Ceramic Primer Ceramic Coupling Agent

K-Number: K242749 · 2024-11-08

ApplicantRizhao Huge Biomaterials Company, Ltd.
Decision Date2024-11-08
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TopCEM Ceramic Primer Ceramic Coupling Agent is a medical device manufactured by Rizhao Huge Biomaterials Company, Ltd.. It received FDA 510(k) clearance on 2024-11-08 under approval number K242749. 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 TopCEM Ceramic Primer Ceramic Coupling Agent?

TopCEM Ceramic Primer Ceramic Coupling Agent is a medical device that received FDA 510(k) clearance on 2024-11-08. It is manufactured by Rizhao Huge Biomaterials Company, Ltd.. The 510(k) number is K242749.

When was TopCEM Ceramic Primer Ceramic Coupling Agent approved by the FDA?

TopCEM Ceramic Primer Ceramic Coupling Agent received FDA 510(k) clearance on 2024-11-08, under approval number K242749.

What company makes TopCEM Ceramic Primer Ceramic Coupling Agent?

TopCEM Ceramic Primer Ceramic Coupling Agent is manufactured by Rizhao Huge Biomaterials Company, Ltd..

What is the FDA product code for TopCEM Ceramic Primer Ceramic Coupling Agent?

The FDA product code for TopCEM Ceramic Primer Ceramic Coupling Agent is KLE.

Other Devices by Rizhao Huge Biomaterials Company, Ltd.

K201790Dual Cure Resin Cement K201787Light Cure Dental Adhesive K202063TrusFIL Universal Composite Restorative K221510TrusFIL-Flow Flowable Composite Restorative K221450Phosphoric Acid Etching Gel K233082TopCEM Dual Cure Resin Cement

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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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