Biotem Co., Ltd.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Biotem Co., Ltd.” (first 2017, latest 2023), across 1 product code in 1 review panel. Median 510(k) review time under this name: 310 days. Since 2017 the median was 310 days, against 217 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 |
|---|---|---|
| 2017 | 1 | 221 |
| 2018 | 2 | 282 |
| 2019 | 0 | — |
| 2020 | 1 | 345 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 2 | 334 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Biotem Co., Ltd. took a median 310 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 217 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DZE | Implant, Endosseous, Root-Form | 6 | 6 |
Review panels
- Dental (6)
Most recent Biotem Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K222142 | BR SLA Type Implant System | DZE | 2023-06-24 | 339 |
| K222144 | IR SLA Type Implant System | DZE | 2023-06-14 | 329 |
| K190641 | AR_N SLA Type Implant System | DZE | 2020-02-21 | 345 |
| K171179 | BR Type Implant System | DZE | 2018-02-09 | 291 |
| K171297 | AR_N Type Implant System | DZE | 2018-01-31 | 274 |
| K171185 | IR Type Implant System | DZE | 2017-12-01 | 221 |
Recalls
openFDA lists no recalls under a recalling firm named Biotem 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Biotem Co., Ltd.?
FDA lists 6 510(k) clearances under the applicant name “Biotem Co., Ltd.” (first 2017, latest 2023), across 1 product code 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 Biotem Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Biotem Co., Ltd. is 310 days. Since 2017: 310 days, versus 217 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Biotem Co., Ltd.?
The most frequent FDA product codes under this applicant name are DZE (Implant, Endosseous, Root-Form, 6).
Next steps
- See all 6 Biotem Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code DZE, Biotem 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.