Osstem Implant Co., Ltd.: FDA filings under this applicant name
FDA lists 68 510(k) clearances under the applicant name “Osstem Implant Co., Ltd.” (first 2006, latest 2026), across 10 product codes in 2 review panels. Median 510(k) review time under this name: 152 days. Since 2017 the median was 169 days, against 167 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 |
|---|---|---|
| 2012 | 5 | 143 |
| 2013 | 4 | 198 |
| 2014 | 4 | 169 |
| 2015 | 1 | 131 |
| 2016 | 4 | 242 |
| 2017 | 7 | 289 |
| 2018 | 2 | 180 |
| 2019 | 5 | 298 |
| 2020 | 1 | 104 |
| 2021 | 3 | 70 |
| 2022 | 1 | 90 |
| 2023 | 3 | 145 |
| 2024 | 3 | 145 |
| 2025 | 1 | 83 |
| 2026 | 1 | 300 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Osstem Implant Co., Ltd. took a median 169 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 167 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DZE | Implant, Endosseous, Root-Form | 27 | 27 |
| NHA | Abutment, Implant, Dental, Endosseous | 18 | 18 |
| ELW | Material, Impression | 5 | 5 |
| DZL | Screw, Fixation, Intraosseous | 3 | 3 |
| EHD | Unit, X-Ray, Extraoral With Timer | 3 | 3 |
| JEY | Plate, Bone | 3 | 3 |
| OAS | X-Ray, Tomography, Computed, Dental | 3 | 3 |
| EIA | Unit, Operative Dental | 2 | 2 |
| EIH | Powder, Porcelain | 2 | 2 |
| OAT | Implant, Endosseous, Orthodontic | 2 | 2 |
Review panels
Most recent Osstem Implant Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K251434 | Healing Abutment System | NHA | 2026-03-04 | 300 |
| K251569 | Bone Screw | DZL | 2025-08-13 | 83 |
| K242521 | Estar-ZE | EIH | 2024-11-20 | 89 |
| K233806 | T2 Plus | OAS | 2024-09-06 | 282 |
| K233194 | TS Abutment System | NHA | 2024-02-20 | 145 |
| K232220 | SS Abutment System | NHA | 2023-12-05 | 132 |
| K232012 | N1 | EHD | 2023-11-28 | 145 |
| K222778 | Osstem Implant System | DZE | 2023-09-23 | 374 |
| K221684 | Osstem Abutment System | NHA | 2022-09-08 | 90 |
| K212303 | T2 | OAS | 2021-09-21 | 60 |
58 earlier clearances. See the full list in Caduvo.
Recalls
3 product recalls in 1 recall events; 3 initiated in the last five years. Most recent: 2025-08-26.
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.
- Osstem Co., Ltd. (1 510(k)s)
- Osstem Germany GmbH (1 510(k)s)
- Osstem Implant Co., Ltd. Chair Business (1 510(k)s)
- Osstem Implant Company., Ltd. Chair Business (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Osstem Implant Co., Ltd.?
FDA lists 68 510(k) clearances under the applicant name “Osstem Implant Co., Ltd.” (first 2006, latest 2026), across 10 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Osstem Implant Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Osstem Implant Co., Ltd. is 152 days. Since 2017: 169 days, versus 167 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Osstem Implant Co., Ltd.?
The most frequent FDA product codes under this applicant name are DZE (Implant, Endosseous, Root-Form, 27); NHA (Abutment, Implant, Dental, Endosseous, 18); ELW (Material, Impression, 5).
Next steps
- See all 68 Osstem Implant Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code DZE, Osstem Implant 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.