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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 the device name listed in this FDA 510(k) record. The listed applicant is Rizhao Huge Biomaterials Company, Ltd.. It received FDA 510(k) clearance on 2024-11-08 under 510(k) 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. The listed applicant is Rizhao Huge Biomaterials Company, Ltd.. The 510(k) number is K242749.

When did TopCEM Ceramic Primer Ceramic Coupling Agent receive FDA 510(k) clearance?

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

Who is the listed applicant for TopCEM Ceramic Primer Ceramic Coupling Agent?

The FDA 510(k) record lists Rizhao Huge Biomaterials Company, Ltd. as the applicant. This does not by itself establish the device manufacturer.

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 records listing Rizhao Huge Biomaterials Company, Ltd. as applicant

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Related Devices (Code: KLE)

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.

K260485Any-EtchMediclus Co., Ltd.K260430Porcelain Etch GelBelport Company, Inc., Gingi-PakK252450Adhese 2Ivoclar Vivadent, Inc.K260682Bond-PR™ Universal AdhesivePremier Dental Products CompanyK251587VITA VMLC PrimerVita Zahnfabrik H. Rauter GmbH & Co. Kg.K252151els unibondSaremco Dental AG

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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