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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 K240772
Device Name Dental Zirconia Blank (HT-plus, ST-C, ST-ML, SHT-C, SHT-ML, UT-C, UT-ML, Pro- ML)
Applicant
Hunan Ceramaster Material Technology Co., Ltd.
103, Bldg. B4, Dreamworks, #1 Lantian N. Rd.,
Xingsha Industrial Base
Changsha,  CN 410137
Applicant Contact Bin Wang
Correspondent
Hunan Ceramaster Material Technology Co., Ltd.
103, Bldg. B4, Dreamworks, #1 Lantian N. Rd.,
Xingsha Industrial Base
Changsha,  CN 410137
Correspondent Contact Bin Wang
Regulation Number872.6660
Classification Product Code
EIH  
Date Received03/21/2024
Decision Date 05/20/2024
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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