# K251597: InnerView System

- Pathway: 510(k) (Traditional)
- Applicant: Perimetrics, Inc.
- Decided: Sep 18, 2025 after 114 days
- Product code: EKX (Handpiece, Direct Drive, Ac-Powered)
- Device class: 1
- Regulation: 21 CFR 872.4200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K072213 (2008). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232657: InnerView LC, Perimetrics, Inc. (2023) Summary page 5.

## Indications for use
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.

Source page: https://510kreport.com/device/K251597
Methodology: https://510kreport.com/methodology