Shandong Huge Dental Material Corporation: FDA clearances and approvals
Shandong Huge Dental Material Corporation has 9 FDA 510(k) clearances (first 2016, latest 2026), across 6 product codes in 1 review panel. Median 510(k) review time: 100 days. Since 2017 its median was 97 days, against 122 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2016 | 1 | 117 |
| 2017 | 1 | 389 |
| 2018 | 0 | — |
| 2019 | 1 | 290 |
| 2020 | 1 | 94 |
| 2021 | 0 | — |
| 2022 | 2 | 115 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 1 | 100 |
| 2026 | 2 | 90 |
Review time against the same product codes
Since 2017, Shandong Huge Dental Material Corporation's cleared 510(k)s took a median 97 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 122 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EBI | Resin, Denture, Relining, Repairing, Rebasing | 3 | 3 |
| EMA | Cement, Dental | 2 | 2 |
| EIH | Powder, Porcelain | 1 | 1 |
| ELW | Material, Impression | 1 | 1 |
| MQC | Mouthguard, Prescription | 1 | 1 |
| NXC | Aligner, Sequential | 1 | 1 |
Review panels
- Dental (9)
Most recent Shandong Huge Dental Material Corporation 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260376 | Denture Base | EBI | 2026-05-06 | 90 |
| K260067 | Eternal Art Porcelain Powders | EIH | 2026-04-09 | 90 |
| K251252 | NOBILCAM IMPAK Disc | MQC | 2025-08-01 | 100 |
| K220680 | Denture Base Polymers | EBI | 2022-08-12 | 157 |
| K213994 | Flexible Block | EBI | 2022-03-04 | 73 |
| K201684 | A-Silicone for Bite Registration | ELW | 2020-09-24 | 94 |
| K181747 | Orthodontic Appliance | NXC | 2019-04-18 | 290 |
| K160345 | Glass Ionomer Cement | EMA | 2017-03-03 | 389 |
| K161851 | Glass Ionomer Cement (Luting) | EMA | 2016-10-31 | 117 |
Recalls
openFDA lists no recalls under a recalling firm named Shandong Huge Dental Material Corporation.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Shandong Huge Dental Material Corporation have?
Shandong Huge Dental Material Corporation has 9 FDA 510(k) clearances (first 2016, latest 2026), across 6 product codes in 1 review panel.
How long does FDA take to clear Shandong Huge Dental Material Corporation's 510(k)s?
The median time from FDA receipt to decision across Shandong Huge Dental Material Corporation's cleared 510(k)s is 100 days. Since 2017: 97 days, versus 122 days for all cleared 510(k)s in the same product codes.
What devices does Shandong Huge Dental Material Corporation make?
Its most frequent FDA product codes are EBI (Resin, Denture, Relining, Repairing, Rebasing, 3); EMA (Cement, Dental, 2); EIH (Powder, Porcelain, 1).
Has Shandong Huge Dental Material Corporation had device recalls?
openFDA lists no recalls under a recalling firm name matching Shandong Huge Dental Material Corporation. Related entities may recall under other names.
Next steps
- See all 9 Shandong Huge Dental Material Corporation clearances with predicates and recalls
- Run predicate analysis for product code EBI, Shandong Huge Dental Material Corporation's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.