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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Handpiece, Direct Drive, Ac-Powered
510(k) Number K173920
Device Name LS OIL
Applicant
J. Morita USA, Inc.
9 Mason
Irvine,  CA  92618
Applicant Contact Keith A. Barritt
Correspondent
Fish & Richardson, P.C.
1000 Maine Ave., SW, Suite 1000
Washington,  DC  20024
Correspondent Contact Keith A. Barritt
Regulation Number872.4200
Classification Product Code
EKX  
Date Received12/22/2017
Decision Date 10/11/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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