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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Resin, Denture, Relining, Repairing, Rebasing
510(k) Number K242884
Device Name Additively Manufactured Denture Resin
Applicant
Aidite (Qinhuangdao) Technology Co., Ltd.
#9 Dushan Rd.
Economic And Technological Development Zone
Qinhuangdao,  CN 066004
Applicant Contact Qianqian Liu
Correspondent
Shanghai Truthful Information Technology Co., Ltd.
Rm. 1801, # 161 E. Lujiazui Rd.
Pudong Shanghai,  CN 200120
Correspondent Contact Boyle Wang
Regulation Number872.3760
Classification Product Code
EBI  
Date Received09/23/2024
Decision Date 11/22/2024
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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