Primescan 2

The Primescan 2 is an intraoral scanner that uses fluorescence and near-infrared light imaging modes to help dentists detect dental caries (cavities) on visible tooth surfaces, between teeth, and tooth cracks. It illuminates teeth with 405 nm UV light for fluorescence-based caries detection and 850 nm near-infrared light to visualize structural defects. A disposable or reusable sleeve covers the scanner tip during patient use.

Both Primescan 2 and the predicate DEXIS CariVu 3-in-1 share fluorescence mode (405 nm), transillumination/near-infrared mode (850 nm), and CMOS sensor technology. Differences include: Primescan 2 uses single-use and multi-use sleeves while the predicate uses a disposable sheath with reusable tip; Primescan 2 is wireless with battery/Wi-Fi and cloud-based software versus the predicate's wired configuration; and Primescan 2 has different spatial resolution and focal length specifications.

IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, EN 62471 (photobiological safety), IEEE ANSI USEMCSC C63.27, FDA reprocessing guidance, ISO 17664-1, AAMI TIR12, AAMI ST98, ISO 10993-1/5/10/23 (biocompatibility), IEC 62304, and FDA cybersecurity guidance for medical devices.

The devices are substantially equivalent because they share the same intended use (caries and crack detection) and fundamental operating principles (fluorescence and near-infrared imaging modes with CMOS sensors). Although Primescan 2 differs in wireless capability, software location, sleeve design, and resolution specifications, performance validation testing showed Primescan 2 performs as well as the predicate, and these differences do not raise new safety or effectiveness concerns. The technological differences are design variations that do not alter the basic function or diagnostic capability.