Takara Belmont Corporation: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Takara Belmont Corporation” (first 2007, latest 2017), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 126 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 | 1 | 107 |
| 2015 | 0 | — |
| 2016 | 1 | 178 |
| 2017 | 1 | 126 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Takara Belmont Corporation took a median 126 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 116 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EHD | Unit, X-Ray, Extraoral With Timer | 2 | 2 |
| MUH | System, X-Ray, Extraoral Source, Digital | 2 | 2 |
| EIA | Unit, Operative Dental | 1 | 1 |
| JAK | System, X-Ray, Tomography, Computed | 1 | 1 |
| OAS | X-Ray, Tomography, Computed, Dental | 1 | 1 |
Review panels
Most recent Takara Belmont Corporation 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K163175 | Bel-Cypher Pro | MUH | 2017-03-20 | 126 |
| K152100 | Evogue Dental Unit | EIA | 2016-01-22 | 178 |
| K141293 | PHOT-X IIS MODEL 505 | EHD | 2014-09-03 | 107 |
| K101181 | BEL-CAT | OAS | 2011-07-19 | 448 |
| K110160 | BEL-CYPHER N | MUH | 2011-02-17 | 29 |
| K093240 | BELRAY II | EHD | 2010-03-22 | 158 |
| K072574 | ALPHARD CONE BEAM CT, MODEL X178 | JAK | 2007-10-18 | 35 |
Recalls
openFDA lists no recalls under a recalling firm named Takara Belmont Corporation.
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.
- Takara Belmont USA, Inc. (6 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Takara Belmont Corporation?
FDA lists 7 510(k) clearances under the applicant name “Takara Belmont Corporation” (first 2007, latest 2017), across 5 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 Takara Belmont Corporation?
The median time from FDA receipt to decision across 510(k)s cleared under the name Takara Belmont Corporation is 126 days.
Which FDA product codes appear under Takara Belmont Corporation?
The most frequent FDA product codes under this applicant name are EHD (Unit, X-Ray, Extraoral With Timer, 2); MUH (System, X-Ray, Extraoral Source, Digital, 2); EIA (Unit, Operative Dental, 1).
Next steps
- See all 7 Takara Belmont Corporation clearances with predicates and recalls
- Run predicate analysis for product code EHD, Takara Belmont Corporation'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.