Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Rizhao Huge Biomaterials Company, Ltd. · Predicate Candidate Screening
13 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
101 daysmedian FDA review time
154 days90th percentile
13clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252785 | TopCEM Vigor SA Self-Adhesive Resin Cement | Rizhao Huge Biomaterials Company, Ltd. | 2025-12-12 | 101 | 0 |
| K251271 | TempFIT Temporary Crown and Bridge Resin | Rizhao Huge Biomaterials Company, Ltd. | 2025-06-23 | 60 | 0 |
| K242530 | HF-Etchant Hydrofluoric Acid Etching Gel | Rizhao Huge Biomaterials Company, Ltd. | 2024-12-20 | 116 | 0 |
| K242572 | TopCEM-Try in Veneer Try-in Gel | Rizhao Huge Biomaterials Company, Ltd. | 2024-12-20 | 113 | 0 |
| K242749 | TopCEM Ceramic Primer Ceramic Coupling Agent | Rizhao Huge Biomaterials Company, Ltd. | 2024-11-08 | 57 | 0 |
| K241204 | TopCEM-Veneer Light Cure Veneer Cement | Rizhao Huge Biomaterials Company, Ltd. | 2024-06-28 | 59 | 0 |
| K233082 | TopCEM Dual Cure Resin Cement | Rizhao Huge Biomaterials Company, Ltd. | 2023-12-22 | 87 | 0 |
| K230455 | Enamel Coating Resin | Rizhao Huge Biomaterials Company, Ltd. | 2023-07-25 | 154 | 0 |
| K221510 | TrusFIL-Flow Flowable Composite Restorative | Rizhao Huge Biomaterials Company, Ltd. | 2022-10-12 | 141 | 0 |
| K221450 | Phosphoric Acid Etching Gel | Rizhao Huge Biomaterials Company, Ltd. | 2022-09-12 | 117 | 0 |
| K202063 | TrusFIL Universal Composite Restorative | Rizhao Huge Biomaterials Company, Ltd. | 2021-10-06 | 436 | 0 |
| K201790 | Dual Cure Resin Cement | Rizhao Huge Biomaterials Company, Ltd. | 2020-09-29 | 91 | 0 |
| K201787 | Light Cure Dental Adhesive | Rizhao Huge Biomaterials Company, Ltd. | 2020-09-25 | 87 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda