Takara Belmont USA, Inc.
Somerset, NJ, US
TAKARA BELMONT USA, INC. appears in FDA device records in Somerset, NJ. FDA records list 6 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 6 510(k) clearances for Takara Belmont USA, Inc. between 2004 and 2011. The busiest year on record is 2004, with 3. The most recent is 2011, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2004 | 3 |
| 2006 | 1 |
| 2007 | 1 |
| 2011 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K102456 | INTRAORAL BELSENSOR GOLD | MUH | Substantially Equivalent | |
| K072273 | BELMONT QUOLIS 5000 SERIES DENTAL UNIT | NRD | Substantially Equivalent | |
| K062529 | BELMAX CM MODEL X168 | MUH | Substantially Equivalent | |
| K041834 | ADR PLUS SSXI IMAGING DEVICE FOR X-RAY SYSTEMS SUCH AS X-CALIBER, X-CALIBER CM, ANA-BEL AND ANA-BEL CM | MUH | Substantially Equivalent | |
| K042260 | PHOT-X II, MODEL 303 | EHD | Substantially Equivalent | |
| K040748 | ANA-BEL, MODEL 087D AND ANA-BEL CM, MODEL 187-CM | EHD | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2243976 | 1000080622 | TAKARA BELMONT USA, INC. | 101 BELMONT DR., SOMERSET, NJ 08873 US | 2026 | No device listings on this registration |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain