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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 K210884
Device Name 1Derful HS, 1Derful HT
Applicant
1derful, Inc.
38345 Donigan Rd.
Brookshire,  TX  77423
Applicant Contact Mohamad Alkassab
Correspondent
Rac Dental Technologies
27134 Paseo Espada, B201
San Juan Capistrano,  CA  92675
Correspondent Contact Robin Carden
Regulation Number872.6660
Classification Product Code
EIH  
Date Received03/25/2021
Decision Date 07/27/2021
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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