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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name abutment, implant, dental, endosseous
510(k) Number K232271
Device Name SIMDA abutment
Simda Co., Ltd.
156-4, Gamjeon-dong
Busan,  KR
Applicant Contact Cha Young Woo
Simda Co., Ltd.
156-4, Gamjeon-dong
Busan,  KR
Correspondent Contact Cha Young Woo
Regulation Number872.3630
Classification Product Code
Date Received07/31/2023
Decision Date 10/26/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No