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Rizhao Huge Biomaterials Company, Ltd.

FDA 510(k) & PMA Approved Devices — 13 products

Total Devices13
Categories5
Latest FDA decision2025-12-12
TypeNumberDevice NameCodeDateActions
510(k) K252785 TopCEM Vigor SA Self-Adhesive Resin CementEMA2025-12-12 View
510(k) K251271 TempFIT Temporary Crown and Bridge ResinEBG2025-06-23 View
510(k) K242572 TopCEM-Try in Veneer Try-in GelEBF2024-12-20 View
510(k) K242530 HF-Etchant Hydrofluoric Acid Etching GelKLE2024-12-20 View
510(k) K242749 TopCEM Ceramic Primer Ceramic Coupling AgentKLE2024-11-08 View
510(k) K241204 TopCEM-Veneer Light Cure Veneer CementEMA2024-06-28 View
510(k) K233082 TopCEM Dual Cure Resin CementEBF2023-12-22 View
510(k) K230455 Enamel Coating ResinEBC2023-07-25 View
510(k) K221510 TrusFIL-Flow Flowable Composite RestorativeEBF2022-10-12 View
510(k) K221450 Phosphoric Acid Etching GelKLE2022-09-12 View
510(k) K202063 TrusFIL Universal Composite RestorativeEBF2021-10-06 View
510(k) K201790 Dual Cure Resin CementEMA2020-09-29 View
510(k) K201787 Light Cure Dental AdhesiveKLE2020-09-25 View
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