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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 K250393
Device Name ZircaGlow & ZircaGlow HT Zirconia
Applicant
United Zirconia
Land Plot #164-D
North Katameya Rd.
Cairo,  EG
Applicant Contact Kanal Ebeid
Correspondent
T² & Company
1 Baya St.
Cairo,  CA  92694
Correspondent Contact Tim Torbenson
Regulation Number872.6660
Classification Product Code
EIH  
Date Received02/12/2025
Decision Date 05/12/2025
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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