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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 K251605
Device Name DIMPLO Implant System
Applicant
DIMPLO, Ltd.
2f, 16, Hwangsaeal-Ro, Yeonje-Gu
Busan,  KR 47507
Applicant Contact Jiyeon Sung
Correspondent
DIMPLO, Ltd.
2f, 16, Hwangsaeal-Ro, Yeonje-Gu
Busan,  KR 47507
Correspondent Contact Jiyeon Sung
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received05/27/2025
Decision Date 12/22/2025
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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