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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cement, Dental
510(k) Number K262983
Device Name EsTemp Implant
Applicant
Spident Co., Ltd.
203 & 312, Korea Industrial Complex, 722, Gojan-Dong, Namdon
Incheon,  KR 405-821
Applicant Contact Seong Kiyoung
Correspondent
Spident Co., Ltd.
203 & 312, Korea Industrial Complex, 722, Gojan-Dong, Namdon
Incheon,  KR 405-821
Correspondent Contact Seong Kiyoung
Regulation Number872.3275
Classification Product Code
EMA  
Date Received08/27/2026
Decision Date 09/25/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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