Chengdu Besmile Medical Technology Co., Ltd.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Chengdu Besmile Medical Technology Co., Ltd.” (first 2024, latest 2026), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 194 days. Since 2017 the median was 194 days, against 174 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 |
|---|---|---|
| 2024 | 3 | 144 |
| 2025 | 1 | 354 |
| 2026 | 1 | 194 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Chengdu Besmile Medical Technology Co., Ltd. took a median 194 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 174 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EIH | Powder, Porcelain | 3 | 3 |
| DZE | Implant, Endosseous, Root-Form | 1 | 1 |
| NHA | Abutment, Implant, Dental, Endosseous | 1 | 1 |
Review panels
- Dental (5)
Most recent Chengdu Besmile Medical Technology Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252286 | BIORES Dental Implant System | DZE | 2026-02-02 | 194 |
| K242768 | Customized Abutment and Screw | NHA | 2025-09-02 | 354 |
| K232682 | Pre-Sintered Zirconia Coloring Liquid | EIH | 2024-03-19 | 200 |
| K232676 | Dental Porcelain Powder | EIH | 2024-01-23 | 144 |
| K232673 | Dental Glass Ceramics | EIH | 2024-01-23 | 144 |
Recalls
openFDA lists no recalls under a recalling firm named Chengdu Besmile Medical 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.
- Chengdu Cryo-Push Medical Technology Co.,Ltd (4 510(k)s)
- Chengdu Daxan Innovative Medical Tech. Co., Ltd. (2 510(k)s)
- Chengdu Besmile Biotechnology Co., Ltd. (1 510(k)s)
- Chengdu Shifeng Medical Technology Co., Ltd. (1 510(k)s)
- Chengdu Wision Medical Device Co., Ltd. (1 510(k)s)
- Chengdu Xinjin Shifeng Med Appratus Inst Co., Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Chengdu Besmile Medical Technology Co., Ltd.?
FDA lists 5 510(k) clearances under the applicant name “Chengdu Besmile Medical Technology Co., Ltd.” (first 2024, 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 Chengdu Besmile Medical Technology Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Chengdu Besmile Medical Technology Co., Ltd. is 194 days. Since 2017: 194 days, versus 174 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Chengdu Besmile Medical Technology Co., Ltd.?
The most frequent FDA product codes under this applicant name are EIH (Powder, Porcelain, 3); DZE (Implant, Endosseous, Root-Form, 1); NHA (Abutment, Implant, Dental, Endosseous, 1).
Next steps
- See all 5 Chengdu Besmile Medical Technology Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code EIH, Chengdu Besmile Medical 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.