Sytec Dentascan

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

510(k) Number

K914305 ↗

FDA Product Code

JAK

Device Class

Class II

Regulation

21 CFR Part 892.1750

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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• What is the Sytec Dentascan used for?

  The Sytec Dentascan is a computed tomography (CT) system specifically designed for dental imaging. It uses X-ray technology to generate cross-sectional images of dental structures, enabling radiologists to visualize teeth, jawbone, and surrounding anatomy with high precision. This detailed imaging supports accurate diagnosis of dental conditions, including planning for procedures like implants or extractions.

• How is the Sytec Dentascan supplied and what are its regulatory details?

  The Sytec Dentascan is supplied as a Class II medical device under the FDA’s 510(k) clearance process. It received clearance (K914305) in 1992 after review by the Radiology Advisory Committee, confirming its substantial equivalence to a predicate device. The system is intended for use in radiology settings and complies with special controls for computed tomography systems as defined by the FDA.

• Is the Sytec Dentascan sterile or single-use?

  The Sytec Dentascan is not specified as a sterile or single-use device in its regulatory documentation. It is designed as a reusable medical instrument for professional radiology use, adhering to standard maintenance and cleaning protocols for CT systems.

• What type of regulatory approval does the Sytec Dentascan hold?

  The Sytec Dentascan holds FDA 510(k) clearance (K914305), granted through the traditional clearance process. This approval was issued in 1992 following a review by the Radiology Advisory Committee, confirming its compliance with applicable regulations for computed tomography systems under product code JAK.

• Can this device be used for imaging beyond dental structures?

  While the Sytec Dentascan is primarily designed for dental imaging, its computed tomography capabilities allow for detailed visualization of the maxillofacial region, including teeth, jawbone, and adjacent soft tissues. However, its intended use is specifically for dental diagnostics, and clinical applications should align with the manufacturer’s instructions and regulatory guidance.