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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Handpiece, Air-Powered, Dental
510(k) Number K163483
Device Name PANA SPRAY Plus
Applicant
Nakanishi, Inc.
700 Shimohinata
Kanuma-Shi,  JP 322-8666
Applicant Contact Kimihiko Satoh
Correspondent
Ken Block Consulting
1201 Richardson Dr., Suite 160
Richardson,  TX  75080
Correspondent Contact Diane Rutherford
Regulation Number872.4200
Classification Product Code
EFB  
Date Received12/12/2016
Decision Date 08/15/2017
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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