InnerView System

The InnerView System is a wireless handheld dental device that measures tooth and implant mobility using light percussion. It applies a non-destructive percussion to the buccal surface of teeth or implants and analyzes the energy response to quantify external mobility (Mobility output) and internal structural mobility (NFE output). The device consists of a wireless handpiece, base station, disposable tips, and cloud-based software for data analysis.

The subject device is virtually identical to the predicate InnerView LC except for two key differences: (1) it uses four taps per measurement instead of five, and (2) it adds a new NFE algorithm that measures internal mobility by analyzing the shape of the energy response graph against a standard Gaussian curve. Both devices use the same electromagnetic percussion mechanism, piezo sensor for energy detection, wireless data transmission, and hardware components. The maximum percussion force remains less than 36 N in both.

ISO 10993-1:2018 and ISO 7405:2018 for biocompatibility testing; IEC 60601-1 for electrical safety; IEC 60601-1-2 for electromagnetic compatibility; IEC 62304 for medical device software lifecycle processes. Biocompatibility testing included cytotoxicity, sensitization, and irritation assessments. Software verification and validation followed FDA guidance on device software functions and cyber security management.

The InnerView System is substantially equivalent because it uses identical hardware, the same percussion measurement methodology, and the same fundamental ERG data collection as the predicate. The reduction from five to four taps was verified not to impact clinical performance. The new NFE algorithm, while providing an additional output, derives from the same ERG data and measurement technique as the Mobility output; both are measurement tools rather than diagnostic devices. In-vitro bench testing confirmed the NFE algorithm produces distinct and significantly different values for samples with and without induced internal mobility, and in-vivo clinical data demonstrated the utility of the new measurement. No new safety or effectiveness questions are introduced because the underlying physics, hardware, and clinical workflow remain unchanged.