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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Impression
510(k) Number K191034
Device Name VPS Impression Material
Applicant
Hygedent, Inc.
Rm. 210c, Bldg. 4, No 5 Chaoqian Rd.,
Science Industry Park, Changping
Beijing,  CN 102299
Applicant Contact Peng Wang
Correspondent
Hygedent, Inc.
Rm. 210c, Bldg. 4, No 5 Chaoqian Rd.,
Science Industry Park, Changping
Beijing,  CN 102299
Correspondent Contact Peng Wang
Regulation Number872.3660
Classification Product Code
ELW  
Date Received04/18/2019
Decision Date 09/04/2019
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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