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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Adhesive, Bracket And Tooth Conditioner, Resin
510(k) Number K261129
Device Name OrthoFit
Applicant
Spident Co., Ltd.
203 & 312, Korea Industrial Complex, 722, Gojan-Dong, Namdon
Incheon,  KR 405-821
Applicant Contact Choi Eunok
Correspondent
Spident Co., Ltd.
203 & 312, Korea Industrial Complex, 722, Gojan-Dong, Namdon
Incheon,  KR 405-821
Correspondent Contact Choi Eunok
Regulation Number872.3750
Classification Product Code
DYH  
Date Received04/06/2026
Decision Date 07/02/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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