Neobiotech Co., Ltd.: FDA filings under this applicant name
FDA lists 17 510(k) clearances under the applicant name “Neobiotech Co., Ltd.” (first 2004, latest 2024), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 149 days. Since 2017 the median was 156 days, against 192 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 | 4 | 140 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 1 | 277 |
| 2018 | 4 | 152 |
| 2019 | 1 | 135 |
| 2020 | 0 | — |
| 2021 | 1 | 119 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 2 | 258 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Neobiotech Co., Ltd. took a median 156 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 192 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DZE | Implant, Endosseous, Root-Form | 13 | 13 |
| NHA | Abutment, Implant, Dental, Endosseous | 2 | 2 |
| DZL | Screw, Fixation, Intraosseous | 1 | 1 |
| JEY | Plate, Bone | 1 | 1 |
Review panels
- Dental (17)
Most recent Neobiotech Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K232528 | Protective Cap | NHA | 2024-04-30 | 253 |
| K232049 | IS-III active Short Implant | DZE | 2024-03-28 | 262 |
| K210903 | IS Multi Unit Abutment System | NHA | 2021-07-23 | 119 |
| K190849 | IS-III active System_S-narrow Type | DZE | 2019-08-14 | 135 |
| K181137 | IT-III active System | DZE | 2018-11-16 | 200 |
| K181138 | IS-III active System | DZE | 2018-10-03 | 156 |
| K181178 | S-mini active Fixture | DZE | 2018-07-24 | 83 |
| K173938 | IS-III HActive Fixture | DZE | 2018-05-24 | 149 |
| K160991 | Neo GBR System | DZL | 2017-01-10 | 277 |
| K120503 | CMI IMPLANT IS II ACTIVE | DZE | 2012-06-18 | 118 |
7 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Neobiotech 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 Neobiotech Co., Ltd.?
FDA lists 17 510(k) clearances under the applicant name “Neobiotech Co., Ltd.” (first 2004, latest 2024), across 4 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 Neobiotech Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Neobiotech Co., Ltd. is 149 days. Since 2017: 156 days, versus 192 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Neobiotech Co., Ltd.?
The most frequent FDA product codes under this applicant name are DZE (Implant, Endosseous, Root-Form, 13); NHA (Abutment, Implant, Dental, Endosseous, 2); DZL (Screw, Fixation, Intraosseous, 1).
Next steps
- See all 17 Neobiotech Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code DZE, Neobiotech 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.