Rizhao Huge Biomaterials Company, Ltd.
Rizhao Shandong, CN
RIZHAO HUGE BIOMATERIALS COMPANY, LTD. appears in FDA device records in Rizhao Shandong, CN. FDA records list 13 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 13 510(k) clearances for Rizhao Huge Biomaterials Company, Ltd. between 2020 and 2025. The busiest year on record is 2024, with 4. The most recent is 2025, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2020 | 2 |
| 2021 | 1 |
| 2022 | 2 |
| 2023 | 2 |
| 2024 | 4 |
| 2025 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K252785 | TopCEM Vigor SA Self-Adhesive Resin Cement | EMA | Substantially Equivalent | |
| K251271 | TempFIT Temporary Crown and Bridge Resin | EBG | Substantially Equivalent | |
| K242572 | TopCEM-Try in Veneer Try-in Gel | EBF | Substantially Equivalent | |
| K242530 | HF-Etchant Hydrofluoric Acid Etching Gel | KLE | Substantially Equivalent | |
| K242749 | TopCEM Ceramic Primer Ceramic Coupling Agent | KLE | Substantially Equivalent | |
| K241204 | TopCEM-Veneer Light Cure Veneer Cement | EMA | Substantially Equivalent | |
| K233082 | TopCEM Dual Cure Resin Cement | EBF | Substantially Equivalent | |
| K230455 | Enamel Coating Resin | EBC | Substantially Equivalent | |
| K221510 | TrusFIL-Flow Flowable Composite Restorative | EBF | Substantially Equivalent | |
| K221450 | Phosphoric Acid Etching Gel | KLE | Substantially Equivalent | |
| K202063 | TrusFIL Universal Composite Restorative | EBF | Substantially Equivalent | |
| K201790 | Dual Cure Resin Cement | EMA | Substantially Equivalent | |
| K201787 | Light Cure Dental Adhesive | KLE | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3017674095 | 3017674095 | RIZHAO HUGE BIOMATERIALS COMPANY, LTD. | No.2 North Zhaoyang Road, District of Donggang, Rizhao Shandong 276800 CN | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain