LS Oil

FDA 510(k) K173920 · J. Morita USA, Inc.

Substantially Equivalent

510(k) numberK173920

Submission

Device name
LS Oil
Applicant
J. Morita USA, Inc.
Irvine, CA, US
Received
December 22, 2017
Decision date
October 11, 2018
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
EKX – Handpiece, Direct Drive, Ac-Powered
Device class
Class I (low risk)
Regulation
21 CFR 872.4200
Specialty
Dental

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Questions and answers

When was LS Oil cleared by the FDA?

LS Oil (K173920) received a 510(k) decision of Substantially Equivalent on October 11, 2018, 293 days after the submission was received.

What is the product code of K173920?

The FDA product code is EKX – Handpiece, Direct Drive, Ac-Powered, a Class I (low risk) device regulated under 21 CFR 872.4200.