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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 K191304
Device Name EthanZir Zirconia
Applicant
Besorah Dental Solutions NZ Limited
17/9 Chonny Crescent, Manurewa
Auckland,  NZ 2102
Applicant Contact Jobin Jose
Correspondent
RAC Corporation
27134 Paseo Espada
San Juan Capistrano,  CA  92675
Correspondent Contact Robin A. Carden
Regulation Number872.6660
Classification Product Code
EIH  
Date Received05/14/2019
Decision Date 11/04/2019
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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