Search Results

The InnerView System is intended to precisely measure the damping characteristics of the periodontium and its associated fixed structures (teeth and/or implants). It can provide data to quantify tooth and/or dental implant mobility by producing two distinct outputs. InnerView's Mobility quantifies the external tooth and/or implant mobility. InnerView's NFE quantifies the internal mobility within the tooth and/or implant structure.

The InnerView System is an electromagnetically driven percussion system designed for dental professionals to collect percussion data of intraoral sites such as teeth and/or dental implants. The device utilizes non-destructive quantitative percussion diagnostics (QPD), a mechanics-based methodology to measure the damping capacity of a tooth and implant by applying light percussion to its buccal surface.

The InnerView System consists of a wireless handheld handpiece, a base station, single-use disposable tips, and software. A USB cable connects the base station to the user's PC. The handpiece and base station are automatically paired when the handpiece is placed in the base station. The base station also functions as a charger for the handpiece when docked. A fresh disposable tip must be attached to the handpiece before each new procedure and replaced after each patient use.

The percussion response captured by the handpiece is wirelessly transmitted to the base station, then forwarded to the PC via USB, and subsequently to the Cloud-based software for analysis and calculations. The percussion data is captured in an energy response graph (ERG), which depicts the mechanical response of the intraoral site as a function of time. InnerView proprietary software algorithms analyze the ERG data and, through the user interface, display two independent outputs: Mobility, which quantifies external mobility of the tooth or implant, and NFE, which quantifies internal mobility within the tooth or implant structure.

N/A

Ask a specific question about this device

The Periometer is a unit that precisely measures the damping characteristics of the periodonium and its associated fixed structures (teeth and/or implants). It can provide data to quantify tooth and/or dental implant mobility.

Not Found

I'm sorry, but without access to the full 510(k) submission document for K072213, I cannot provide details on the acceptance criteria, device performance, or study specifics for the Periometer device. The provided text is only the FDA's decision letter and the Indications for Use statement, which does not contain the detailed technical data and study information required to answer your questions.

Ask a specific question about this device