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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powder, Porcelain
510(k) Number K182068
Device Name Erran Dental Zirconia
Applicant
Hangzhou Erran Technology Co., Ltd.
Rm. F3022, Floor 3, Bldg. 1 (South) # 368 Liuhe Rd.
Hangzhou,  CN 310053
Applicant Contact Tingkai Li
Correspondent
Hangzhou Erran Technology Co., Ltd.
Rm. F3022, Floor 3, Bldg. 1 (South) # 368 Liuhe Rd.
Hangzhou,  CN 310053
Correspondent Contact Tingkai Li
Regulation Number872.6660
Classification Product Code
EIH  
Date Received08/01/2018
Decision Date 12/13/2018
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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