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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 K193055
Device Name Purzir Dental Zirconia
Applicant
3DBiocad
1525 N 4th St.
Renton,  WA  98057
Applicant Contact Gyu D. Cho
Correspondent
Emergo Global Consulting, LLC
2500 Bee Cave Rd.
Bldg. 1, Suite 300
Austin,  TX  78746
Correspondent Contact Stuart R. Goldman
Regulation Number872.6660
Classification Product Code
EIH  
Date Received11/01/2019
Decision Date 05/13/2020
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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