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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Denture, Plastic, Teeth
510(k) Number K101029
Device Name KAIFENG/CRYSTAL, KAILI, KAIJING, KAIYUE, MAIST AND KAITONG/ROYAL SYNTHETIC POLYMER TEETH
Applicant
Huge Dental Material Co., Ltd.
3500 S. Dupont Hwy.
Dover,  DE  19901
Applicant Contact JING LI
Correspondent
Huge Dental Material Co., Ltd.
3500 S. Dupont Hwy.
Dover,  DE  19901
Correspondent Contact JING LI
Regulation Number872.3590
Classification Product Code
ELM  
Date Received04/13/2010
Decision Date 08/16/2010
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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