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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthodontic Software
510(k) Number K233625
Device Name RAYDENT SW
Applicant
RAY Co., Ltd.
1F~3F, 4F(Part), 5F, 265, Daeji-Ro, Suji-gu
Yongin-si,  KR 16882
Applicant Contact Huh Soo Ji
Correspondent
RAY Co., Ltd.
1F~3F, 4F(Part), 5F, 265, Daeji-Ro, Suji-gu
Yongin-si,  KR 16882
Correspondent Contact Huh Soo Ji
Regulation Number872.5470
Classification Product Code
PNN  
Subsequent Product Code
NOF  
Date Received11/13/2023
Decision Date 05/16/2024
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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