Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

TopCEM-Try in Veneer Try-in Gel

K-Number: K242572 · 2024-12-20

ApplicantRizhao Huge Biomaterials Company, Ltd.
Decision Date2024-12-20
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TopCEM-Try in Veneer Try-in Gel 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 2024-12-20 under 510(k) number K242572. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TopCEM-Try in Veneer Try-in Gel?

TopCEM-Try in Veneer Try-in Gel is a medical device that received FDA 510(k) clearance on 2024-12-20. The listed applicant is Rizhao Huge Biomaterials Company, Ltd.. The 510(k) number is K242572.

When did TopCEM-Try in Veneer Try-in Gel receive FDA 510(k) clearance?

TopCEM-Try in Veneer Try-in Gel received FDA 510(k) clearance on 2024-12-20, under 510(k) number K242572.

Who is the listed applicant for TopCEM-Try in Veneer Try-in Gel?

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-Try in Veneer Try-in Gel?

The FDA product code for TopCEM-Try in Veneer Try-in Gel is EBF.

Other records listing Rizhao Huge Biomaterials Company, Ltd. 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.

K252785TopCEM Vigor SA Self-Adhesive Resin CementK251271TempFIT Temporary Crown and Bridge ResinK242530HF-Etchant Hydrofluoric Acid Etching GelK242749TopCEM Ceramic Primer Ceramic Coupling AgentK241204TopCEM-Veneer Light Cure Veneer CementK233082TopCEM Dual Cure Resin Cement

View all 13 devices →

Related Devices (Code: EBF)

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.

K262228Transcend Bulk Fill Flowable CompositeUltradent Products, Inc.K261485Tetric plus Fill;Tetric plus FlowIvoclar Vivadent, Inc.K261246SRGC-06GC America, Inc.K261093DIAFILDiaDent Group InternationalK261071DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW (0.5g)DiaDent Group InternationalK260805Dual CoreVericom Co., Ltd.

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.

↑