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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.
Room 210C, Building 4, No 5 Chaoqian Road,
Science Industry Park, Changping
Beijing,  CN 102299
Applicant Contact Peng Wang
Correspondent
Hygedent Inc.
Room 210C, Building 4, No 5 Chaoqian Road,
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
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