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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 K231429
Device Name S-Plant Dental Implant System
Applicant
Idis Co., Ltd.
#1314 ~ #1319, 122, Jomaru-Ro, 385 Beon Gil
Bucheon-Si,  KR 14556
Applicant Contact Aiden Lee
Correspondent
Provision Consulting Group, Inc.
100 N Barranca St., Suite 700
West Covina,  CA  91791
Correspondent Contact Joyce Kwon
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received05/17/2023
Decision Date 12/18/2023
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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