ADR Plus SSXI Imaging Device for X-CALIBER, X-CALIBER CM, ANA-BEL, and ANA-BEL CM

No FDA recalls found in the data synced 22 Oct 2026.

Full name

Adr Plus Ssxi Imaging Device for X-Ray Systems Such As X-Caliber, X-Caliber Cm, Ana-Bel and Ana-Bel Cm

510(k) Number

K041834 ↗

FDA Product Code

MUH

Device Class

Class II

Regulation

21 CFR Part 872.1800

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Ana-Bel, Model 087D and Ana-Bel Cm, Model 187-Cm

  Class II

  FDA 510(k) K040748 Active Cleared 2 Jun 2004

• Belmax Cm Model X168

  Class II

  FDA 510(k) K062529 Active Cleared 5 Oct 2006

• Intraoral Belsensor Gold

  Class II

  FDA 510(k) K102456 Active Cleared 15 Dec 2011

• Phot-X II, Model 303

  Class II

  FDA 510(k) K042260 Active Cleared 7 Sep 2004

• Belmont Quolis 5000 Series Dental Unit

  Class I

  FDA 510(k) K072273 Active Cleared 20 Dec 2007

• What is the ADR Plus SSXI Imaging Device used for?

  The ADR Plus SSXI Imaging Device is a digital, extraoral X-ray imaging system designed specifically for capturing high-quality radiographic images of the dento-maxillofacial region. It replaces traditional radiographic film, providing clearer and more efficient diagnostic imaging for dental professionals. This device integrates with compatible X-ray systems like X-CALIBER, X-CALIBER CM, ANA-BEL, and ANA-BEL CM to improve workflow and diagnostic accuracy.

• How is the ADR Plus SSXI Imaging Device supplied and intended for use?

  The ADR Plus SSXI Imaging Device is supplied as a reusable component for integration with designated X-ray systems in dental settings. It is not intended for standalone use but must be paired with compatible systems (e.g., X-CALIBER, X-CALIBER CM, ANA-BEL, or ANA-BEL CM) to function. Its reusable nature ensures durability and cost-effectiveness over time, though no specific sterility or single-use requirements are mentioned in the documentation.

• Is the ADR Plus SSXI Imaging Device single-use or reusable?

  The ADR Plus SSXI Imaging Device is explicitly described as a reusable component. Unlike disposable film-based systems, this digital device is designed for repeated use within compatible X-ray systems, reducing waste and operational costs. However, proper cleaning and maintenance protocols should be followed to ensure consistent performance and longevity.

• What are the key systems this device is compatible with?

  The ADR Plus SSXI Imaging Device is designed for integration with specific X-ray systems, including the X-CALIBER, X-CALIBER CM, ANA-BEL, and ANA-BEL CM. Compatibility is critical for proper functionality, as the device relies on these systems to capture and process radiographic images of the dento-maxillofacial region. Always verify system compatibility before use.

• What regulatory status does the ADR Plus SSXI Imaging Device hold?

  The ADR Plus SSXI Imaging Device has received FDA 510(k) clearance (K041834) as a Class II medical device under regulation 872.1800. This classification indicates it has been deemed substantially equivalent to a predicate device and meets the necessary safety and performance standards for commercial distribution in the United States. No additional regulatory details beyond this clearance are provided.