Takara Belmont USA, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Takara Belmont USA, Inc.” (first 2004, latest 2011), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 99 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 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MUH | System, X-Ray, Extraoral Source, Digital | 3 | 3 |
| EHD | Unit, X-Ray, Extraoral With Timer | 2 | 2 |
| NRD | Unit, Operative Dental, Accessories | 1 | 1 |
Review panels
Most recent Takara Belmont USA, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K102456 | INTRAORAL BELSENSOR GOLD | MUH | 2011-12-15 | 475 |
| K072273 | BELMONT QUOLIS 5000 SERIES DENTAL UNIT | NRD | 2007-12-20 | 127 |
| K062529 | BELMAX CM MODEL X168 | MUH | 2006-10-05 | 37 |
| K041834 | ADR PLUS SSXI IMAGING DEVICE FOR X-RAY SYSTEMS SUCH AS X-CALIBER, X-CALIBER CM, ANA-BEL AND ANA-BEL CM | MUH | 2004-12-03 | 149 |
| K042260 | PHOT-X II, MODEL 303 | EHD | 2004-09-07 | 15 |
| K040748 | ANA-BEL, MODEL 087D AND ANA-BEL CM, MODEL 187-CM | EHD | 2004-06-02 | 71 |
Recalls
openFDA lists no recalls under a recalling firm named Takara Belmont USA, 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.
- Takara Belmont Corporation (7 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Takara Belmont USA, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Takara Belmont USA, Inc.” (first 2004, latest 2011), across 3 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 USA, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Takara Belmont USA, Inc. is 99 days.
Which FDA product codes appear under Takara Belmont USA, Inc.?
The most frequent FDA product codes under this applicant name are MUH (System, X-Ray, Extraoral Source, Digital, 3); EHD (Unit, X-Ray, Extraoral With Timer, 2); NRD (Unit, Operative Dental, Accessories, 1).
Next steps
- See all 6 Takara Belmont USA, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MUH, Takara Belmont USA, 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.