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Rizhao Huge Biomaterials Company, Ltd.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
13
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K252785TopCEM Vigor SA Self-Adhesive Resin CementDecember 12, 2025
K251271TempFIT Temporary Crown and Bridge ResinJune 23, 2025
K242530HF-Etchant Hydrofluoric Acid Etching GelDecember 20, 2024
K242572TopCEM-Try in Veneer Try-in GelDecember 20, 2024
K242749TopCEM Ceramic Primer Ceramic Coupling AgentNovember 8, 2024
K241204TopCEM-Veneer Light Cure Veneer CementJune 28, 2024
K233082TopCEM Dual Cure Resin CementDecember 22, 2023
K230455Enamel Coating ResinJuly 25, 2023
K221510TrusFIL-Flow Flowable Composite RestorativeOctober 12, 2022
K221450Phosphoric Acid Etching GelSeptember 12, 2022
K202063TrusFIL Universal Composite RestorativeOctober 6, 2021
K201790Dual Cure Resin CementSeptember 29, 2020
K201787Light Cure Dental AdhesiveSeptember 25, 2020