Cleared Traditional

K173920 - LS OIL (FDA 510(k) Clearance)

K173920 · J. Morita USA, Inc. · Dental device

Oct 2018

Decision

293d

Days

Class 1

Risk

K173920 is an FDA 510(k) clearance for the LS OIL. This device is classified as a Handpiece, Direct Drive, Ac-powered (Class I - General Controls, product code EKX).

Submitted by J. Morita USA, Inc. (Irvine, US). The FDA issued a Cleared decision on October 11, 2018, 293 days after receiving the submission on December 22, 2017.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number	K173920 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 22, 2017
Decision Date	October 11, 2018
Days to Decision	293 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF