Aidite (Qinhuangdao) Technology Co., Ltd.: FDA clearances and approvals
Aidite (Qinhuangdao) Technology Co., Ltd. has 16 FDA 510(k) clearances (first 2020, latest 2026), across 5 product codes in 1 review panel. Median 510(k) review time: 84 days. Since 2017 its median was 84 days, against 115 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2020 | 3 | 327 |
| 2021 | 0 | — |
| 2022 | 2 | 78 |
| 2023 | 3 | 84 |
| 2024 | 2 | 44 |
| 2025 | 5 | 69 |
| 2026 | 1 | 196 |
Review time against the same product codes
Since 2017, Aidite (Qinhuangdao) Technology Co., Ltd.'s cleared 510(k)s took a median 84 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 115 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EIH | Powder, Porcelain | 8 | 8 |
| EBF | Material, Tooth Shade, Resin | 3 | 3 |
| EBG | Crown And Bridge, Temporary, Resin | 2 | 2 |
| EBI | Resin, Denture, Relining, Repairing, Rebasing | 2 | 2 |
| NXC | Aligner, Sequential | 1 | 1 |
Review panels
- Dental (16)
Most recent Aidite (Qinhuangdao) Technology Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253036 | Light-curing Coloring Materials (ALCM) | EBF | 2026-04-06 | 196 |
| K251415 | Additively Manufactured Aligner Resin | NXC | 2025-08-27 | 112 |
| K250534 | Biomic Color Opaque | EIH | 2025-05-20 | 85 |
| K250497 | Additive Manufacturing (Light Curing) Crown Bridge Resin | EBF | 2025-04-30 | 69 |
| K250811 | Dental Zirconia Ceramic | EIH | 2025-04-11 | 25 |
| K250025 | Porcelain Powder (Enamel/ Modifier,Stain/Glaze,Stain/Glaze-A,Modeling Fluid ) | EIH | 2025-03-14 | 67 |
| K242884 | Additively Manufactured Denture Resin | EBI | 2024-11-22 | 60 |
| K241715 | Dental Glass Ceramics Blocks (HT,LT,ST) | EIH | 2024-07-12 | 28 |
| K230115 | Denture Base Resin | EBI | 2023-03-17 | 59 |
| K223742 | Dental Ceramic Blocks | EBF | 2023-03-08 | 84 |
6 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Aidite (Qinhuangdao) Technology Co., Ltd..
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 Aidite (Qinhuangdao) Technology Co., Ltd. have?
Aidite (Qinhuangdao) Technology Co., Ltd. has 16 FDA 510(k) clearances (first 2020, latest 2026), across 5 product codes in 1 review panel.
How long does FDA take to clear Aidite (Qinhuangdao) Technology Co., Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Aidite (Qinhuangdao) Technology Co., Ltd.'s cleared 510(k)s is 84 days. Since 2017: 84 days, versus 115 days for all cleared 510(k)s in the same product codes.
What devices does Aidite (Qinhuangdao) Technology Co., Ltd. make?
Its most frequent FDA product codes are EIH (Powder, Porcelain, 8); EBF (Material, Tooth Shade, Resin, 3); EBG (Crown And Bridge, Temporary, Resin, 2).
Has Aidite (Qinhuangdao) Technology Co., Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Aidite (Qinhuangdao) Technology Co., Ltd. Related entities may recall under other names.
Next steps
- See all 16 Aidite (Qinhuangdao) Technology Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code EIH, Aidite (Qinhuangdao) Technology Co., Ltd.'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.