Medical Device Manufacturer · CN , Rizhao City

Rizhao Huge Biomaterials Company, Ltd.

13 submissions · 13 cleared · Since 2020
13
Total
13
Cleared
0
Denied

Rizhao Huge Biomaterials Company, Ltd. — FDA 510(k) Submissions

Rizhao Huge Biomaterials Company, Ltd. has submitted 13 FDA 510(k) premarket notifications since 2020, of which 13 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Agent, Tooth Bonding, Resin, Material, Tooth Shade, Resin, Cement, Dental, Sealant, Pit And Fissure, And Conditioner, Crown And Bridge, Temporary, Resin . Use the specialty filter in the sidebar to narrow results.

13 devices
1–12 of 13
TopCEM Vigor SA Self-Adhesive Resin Cement
K252785 · EMA Cement, Dental · Dental
Dec 2025 101d
TempFIT Temporary Crown and Bridge Resin
K251271 · EBG Crown And Bridge,... · Dental
Jun 2025 60d
HF-Etchant Hydrofluoric Acid Etching Gel
K242530 · KLE Agent, Tooth Bonding, Resin · Dental
Dec 2024 116d
TopCEM-Try in Veneer Try-in Gel
K242572 · EBF Material, Tooth Shade, Resin · Dental
Dec 2024 113d
TopCEM Ceramic Primer Ceramic Coupling Agent
K242749 · KLE Agent, Tooth Bonding, Resin · Dental
Nov 2024 57d
TopCEM-Veneer Light Cure Veneer Cement
K241204 · EMA Cement, Dental · Dental
Jun 2024 59d
TopCEM Dual Cure Resin Cement
K233082 · EBF Material, Tooth Shade, Resin · Dental
Dec 2023 87d
Enamel Coating Resin
K230455 · EBC Sealant, Pit And Fissure,... · Dental
Jul 2023 154d
TrusFIL-Flow Flowable Composite Restorative
K221510 · EBF Material, Tooth Shade, Resin · Dental
Oct 2022 141d
Phosphoric Acid Etching Gel
K221450 · KLE Agent, Tooth Bonding, Resin · Dental
Sep 2022 117d
TrusFIL Universal Composite Restorative
K202063 · EBF Material, Tooth Shade, Resin · Dental
Oct 2021 436d
Dual Cure Resin Cement
K201790 · EMA Cement, Dental · Dental
Sep 2020 91d
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