Biomaterials Korea, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Biomaterials Korea, Inc.” (first 2007, latest 2023), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 251 days. 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 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 1 | 279 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 391 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Biomaterials Korea, Inc. took a median 335 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 225 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OAT | Implant, Endosseous, Orthodontic | 4 | 4 |
| JEY | Plate, Bone | 1 | 1 |
Review panels
- Dental (5)
Most recent Biomaterials Korea, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K222245 | ACR Screw System | OAT | 2023-08-21 | 391 |
| K173623 | Anchor plate | OAT | 2018-08-30 | 279 |
| K110926 | BONE PLATE; BONE SCREW | JEY | 2011-12-08 | 251 |
| K111809 | SL TYPE ORTHODONTIC ANCHOR SCREWS, SPL TYPE ORTHODONTIC ANCHOR SCREWS | OAT | 2011-09-26 | 91 |
| K063495 | C TYPE, CT TYPE, AND SPECIAL TYPE ORTHODONTIC ANCHOR SCREWS | OAT | 2007-07-26 | 248 |
Recalls
openFDA lists no recalls under a recalling firm named Biomaterials Korea, Inc..
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.
- Biomaterials International, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Biomaterials Korea, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Biomaterials Korea, Inc.” (first 2007, latest 2023), across 2 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 Biomaterials Korea, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Biomaterials Korea, Inc. is 251 days.
Which FDA product codes appear under Biomaterials Korea, Inc.?
The most frequent FDA product codes under this applicant name are OAT (Implant, Endosseous, Orthodontic, 4); JEY (Plate, Bone, 1).
Next steps
- See all 5 Biomaterials Korea, Inc. clearances with predicates and recalls
- Run predicate analysis for product code OAT, Biomaterials Korea, Inc.'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.