Cleared Traditional

D function

K203525 · Ito Co., Ltd. · Dental

May 2021

Decision

155d

Days

Class 2

Risk

About This 510(k) Submission

K203525 is an FDA 510(k) clearance for the D function, a Stimulator, Muscle, Powered, Dental (Class II — Special Controls, product code NUW), submitted by Ito Co., Ltd. (Kawaguchi-Shi, JP). The FDA issued a Cleared decision on May 5, 2021, 155 days after receiving the submission on December 1, 2020. This device falls under the Dental review panel. Regulated under 21 CFR 890.5850.

Submission Details

510(k) Number	K203525 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 01, 2020
Decision Date	May 05, 2021
Days to Decision	155 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF

Device Classification

Product Code	NUW — Stimulator, Muscle, Powered, Dental
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 890.5850
Definition	Relief Of Muscle Spasms Associated With Tmj. Muscle Reeducation, Increasing Blood Flow.