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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cement, Dental
510(k) Number K210473
Device Name Nova Glass Cements (Nova Glass L, Nova Glass F, Nova Glass LC, Nova Glass BF, Nova Glass L Plus)
Applicant
Imicryl Dis Malzemeleri Sanayi VE Ticaret AS
Fetih Mahallesi Mahir Sokak No:5/201 Karatay
Konya,  TR 42030
Applicant Contact Hüsamettin Sonmez
Correspondent
Imicryl Dis Malzemeleri Sanayi VE Ticaret AS
Fetih Mahallesi Mahir Sokak No:5/201 Karatay
Konya,  TR 42030
Correspondent Contact Hüsamettin Sonmez
Regulation Number872.3275
Classification Product Code
EMA  
Date Received02/17/2021
Decision Date 11/02/2021
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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