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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implant, Endosseous, Root-Form
510(k) Number K221847
Device Name Ni2 Implant System
Applicant
Newton Implant Systems, Inc.
6272 Flanders Dr. #220
San Diego,  CA  92121
Applicant Contact Pedro Yang
Correspondent
Provision Consulting Group, Inc.
13925 City Center St.
Suite 200
Chino Hills,  CA  91709
Correspondent Contact Joyce Kwon
Regulation Number872.3640
Classification Product Code
DZE  
Date Received06/24/2022
Decision Date 04/11/2024
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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