Cleared Traditional

InnerView System

K251597 · Perimetrics, Inc. · Dental

Sep 2025

Decision

114d

Days

Class 1

Risk

About This 510(k) Submission

K251597 is an FDA 510(k) clearance for the InnerView System, a Handpiece, Direct Drive, Ac-powered (Class I — General Controls, product code EKX), submitted by Perimetrics, Inc. (Redmond, US). The FDA issued a Cleared decision on September 18, 2025, 114 days after receiving the submission on May 27, 2025. This device falls under the Dental review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number	K251597 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 27, 2025
Decision Date	September 18, 2025
Days to Decision	114 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF