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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 K243731
Device Name HEXIM Implant; Samwon General Abutments
Applicant
P&A USA
7535 Little River Turnpike
Suite 310f
Annadale,  VA  22003
Applicant Contact Jung Shin
Correspondent
Rook Quality Systems
1155 Mount Vernon Hwy
Suite 800
Dunwoody,  GA  30338
Correspondent Contact Chandler Thames
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received12/04/2024
Decision Date 07/09/2025
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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