Hangzhou SHINING3D Dental Technology Co., Ltd.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Hangzhou SHINING3D Dental Technology Co., Ltd.” (first 2025, latest 2026), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 1 days. Since 2017 the median was 1 days, against 115 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 |
|---|---|---|
| 2025 | 2 | 2 |
| 2026 | 3 | 1 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Hangzhou SHINING3D Dental Technology Co., Ltd. took a median 1 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 |
|---|---|---|---|
| EBF | Material, Tooth Shade, Resin | 3 | 3 |
| EBG | Crown And Bridge, Temporary, Resin | 1 | 1 |
| EBI | Resin, Denture, Relining, Repairing, Rebasing | 1 | 1 |
Review panels
- Dental (5)
Most recent Hangzhou SHINING3D Dental Technology Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261356 | Dura-Crown | EBF | 2026-04-27 | 3 |
| K261261 | Dura-Arch | EBG | 2026-04-17 | 1 |
| K260170 | LumiCera | EBF | 2026-01-21 | 1 |
| K253053 | Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1) | EBF | 2025-09-23 | 1 |
| K250946 | Denture Base Resin DT20 | EBI | 2025-03-31 | 3 |
Recalls
openFDA lists no recalls under a recalling firm named Hangzhou SHINING3D Dental Technology Co., 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.
- Hangzhou AGS MedTech Co., Ltd. (19 510(k)s)
- Hangzhou AllTest Biotech Co., Ltd. (14 510(k)s)
- Hangzhou Hua'An Medical & Health Instruments Co., (10 510(k)s)
- Hangzhou Clongene Biotech Co., Ltd. (9 510(k)s)
- Hangzhou Qiantang Longyue Biotechnology Co., Ltd. (6 510(k)s)
- Hangzhou Bever Medical Devices Co., Ltd. (4 510(k)s)
- Hangzhou Jimushi Meditech Co., Ltd. (3 510(k)s)
- Hangzhou Kangji Medical Instrument Co., Ltd. (3 510(k)s)
- Hangzhou Laihe Biotech Co., Ltd. (3 510(k)s)
- Hangzhou Tappa Medical Technology Co., Ltd. (3 510(k)s)
- Hangzhou Primecare Medical Co., Ltd. (2 510(k)s)
- Hangzhou Runheng Medical Co., Ltd. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Hangzhou SHINING3D Dental Technology Co., Ltd.?
FDA lists 5 510(k) clearances under the applicant name “Hangzhou SHINING3D Dental Technology Co., Ltd.” (first 2025, latest 2026), across 3 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 Hangzhou SHINING3D Dental Technology Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Hangzhou SHINING3D Dental Technology Co., Ltd. is 1 days. Since 2017: 1 days, versus 115 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Hangzhou SHINING3D Dental Technology Co., Ltd.?
The most frequent FDA product codes under this applicant name are EBF (Material, Tooth Shade, Resin, 3); EBG (Crown And Bridge, Temporary, Resin, 1); EBI (Resin, Denture, Relining, Repairing, Rebasing, 1).
Next steps
- See all 5 Hangzhou SHINING3D Dental Technology Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code EBF, Hangzhou SHINING3D Dental Technology Co., 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.