Takara Belmont USA, Inc.
United StatesFDA applicant, unverified
- Devices
- 6
What Takara Belmont USA, Inc. makes
Takara Belmont USA, Inc. manufactures intraoral dental X-ray imaging devices, including the ANA-BEL and BELMAX CM series for capturing dental radiographs, as well as the INTRAORAL BELSENSOR GOLD sensor for digital imaging. Their portfolio also includes the ADR PLUS SSXI imaging adapter for compatibility with select X-ray systems, the PHOT-X II for dental photography, and the BELMONT QUOLIS 5000 Series dental units for chairside procedures.
The company’s devices are regulated under FDA 510(k) clearance, with products classified as Class I and Class II medical devices. These devices are listed in the FDA’s 510(k) database, reflecting their authorised status for dental imaging and chairside applications. The manufacturer operates from the United States.
Catalogue
Ana-Bel, Model 087D And Ana-Bel Cm, Model 187-Cm Ref K040748
Regimes: 510(k) Registry: 510(k)Belmax Cm Model X168 Ref K062529
Regimes: 510(k) Registry: 510(k)Intraoral Belsensor Gold Ref K102456
Regimes: 510(k) Registry: 510(k)Adr Plus Ssxi Imaging Device For X-Ray Systems Such As X-Caliber, X-Caliber Cm, Ana-Bel And Ana-Bel Cm Ref K041834
Regimes: 510(k) Registry: 510(k)Phot-X Ii, Model 303 Ref K042260
Regimes: 510(k) Registry: 510(k)Belmont Quolis 5000 Series Dental Unit Ref K072273
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Takara Belmont USA, Inc. have in the registry?
The registry currently lists 6 devices for Takara Belmont USA, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Takara Belmont USA, Inc.'s devices?
Among its 6 most recently registered devices, Takara Belmont USA, Inc. has devices listed in FDA 510(k) (6 devices).
What risk classes do Takara Belmont USA, Inc.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for Takara Belmont USA, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Takara Belmont USA, Inc. in the registry?
The most recently registered devices listed for Takara Belmont USA, Inc. include ANA-BEL, MODEL 087D AND ANA-BEL CM, MODEL 187-CM, BELMAX CM MODEL X168, INTRAORAL BELSENSOR GOLD and ADR PLUS SSXI IMAGING DEVICE FOR X-RAY SYSTEMS SUCH AS X-CALIBER, X-CALIBER CM, ANA-BEL AND ANA-BEL CM.