Rizhao Huge Biomaterials Company, Ltd.: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Rizhao Huge Biomaterials Company, Ltd.” (first 2020, latest 2025), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 101 days. Since 2017 the median was 101 days, against 121 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2020 | 2 | 89 |
| 2021 | 1 | 436 |
| 2022 | 2 | 129 |
| 2023 | 2 | 120 |
| 2024 | 4 | 86 |
| 2025 | 2 | 80 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Rizhao Huge Biomaterials Company, Ltd. took a median 101 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 121 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EBF | Material, Tooth Shade, Resin | 4 | 4 |
| KLE | Agent, Tooth Bonding, Resin | 4 | 4 |
| EMA | Cement, Dental | 3 | 3 |
| EBC | Sealant, Pit And Fissure, And Conditioner | 1 | 1 |
| EBG | Crown And Bridge, Temporary, Resin | 1 | 1 |
Review panels
- Dental (13)
Most recent Rizhao Huge Biomaterials Company, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252785 | TopCEM Vigor SA Self-Adhesive Resin Cement | EMA | 2025-12-12 | 101 |
| K251271 | TempFIT Temporary Crown and Bridge Resin | EBG | 2025-06-23 | 60 |
| K242572 | TopCEM-Try in Veneer Try-in Gel | EBF | 2024-12-20 | 113 |
| K242530 | HF-Etchant Hydrofluoric Acid Etching Gel | KLE | 2024-12-20 | 116 |
| K242749 | TopCEM Ceramic Primer Ceramic Coupling Agent | KLE | 2024-11-08 | 57 |
| K241204 | TopCEM-Veneer Light Cure Veneer Cement | EMA | 2024-06-28 | 59 |
| K233082 | TopCEM Dual Cure Resin Cement | EBF | 2023-12-22 | 87 |
| K230455 | Enamel Coating Resin | EBC | 2023-07-25 | 154 |
| K221510 | TrusFIL-Flow Flowable Composite Restorative | EBF | 2022-10-12 | 141 |
| K221450 | Phosphoric Acid Etching Gel | KLE | 2022-09-12 | 117 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Rizhao Huge Biomaterials Company, Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Rizhao Huge Dental Industry Co., Ltd. (3 510(k)s)
- Rizhao Sanqi Medical & Health Articles Co., Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Rizhao Huge Biomaterials Company, Ltd.?
FDA lists 13 510(k) clearances under the applicant name “Rizhao Huge Biomaterials Company, Ltd.” (first 2020, latest 2025), across 5 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Rizhao Huge Biomaterials Company, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Rizhao Huge Biomaterials Company, Ltd. is 101 days. Since 2017: 101 days, versus 121 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Rizhao Huge Biomaterials Company, Ltd.?
The most frequent FDA product codes under this applicant name are EBF (Material, Tooth Shade, Resin, 4); KLE (Agent, Tooth Bonding, Resin, 4); EMA (Cement, Dental, 3).
Next steps
- See all 13 Rizhao Huge Biomaterials Company, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code EBF, Rizhao Huge Biomaterials Company, Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.