Cleared Traditional

K232657 - InnerView LC (FDA 510(k) Clearance)

Class I Dental device.

K232657 · Perimetrics, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2023
Decision
1d
Days
Class 1
Risk

K232657 is an FDA 510(k) clearance for the InnerView LC. Classified as Handpiece, Direct Drive, Ac-powered (product code EKX), Class I - General Controls.

Submitted by Perimetrics, Inc. (Newport Beach, US). The FDA issued a Cleared decision on September 1, 2023 after a review of 1 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4200 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Perimetrics, Inc. devices

Submission Details

510(k) Number K232657 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 2023
Decision Date September 01, 2023
Days to Decision 1 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
126d faster than avg
Panel avg: 127d · This submission: 1d
Pathway characteristics
Predicate-based equivalence. Third-party reviewed.

Device Classification

Product Code EKX Handpiece, Direct Drive, Ac-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4200
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Consultant

Third Party Review Group, LLC
Dave Yungvirt

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - EKX Handpiece, Direct Drive, Ac-powered

All 88
Devices cleared under the same product code (EKX) and FDA review panel - the closest regulatory comparables to K232657.
Alpha Endo Handpiece (Alpha Endo)
K252223 · SHENZHEN SUPERLINE TECHNOLOGY CO., LTD. · Oct 2025
InnerView System
K251597 · Perimetrics, Inc. · Sep 2025
EnDrive (EnDriveUS)
K243692 · Advanced Technology Research (A.T.R.) S.R.L. · Aug 2025
Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO)
K242514 · Shenzhen Rogin Medical Co., Ltd. · Apr 2025
ChecQ (AC100)
K241065 · Dentis Co., Ltd. · Mar 2025
HPR Cordless Hygiene Handpiece
K243911 · Handpiece Headquarters · Dec 2024