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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Agent, Tooth Bonding, Resin
510(k) Number K192913
Device Name R&D Series Nova Compo-B Plus Bottle, R&D Series Nova Compo-B Plus Single Dose
Applicant
Imicryl Dis Malzemeleri Sanayi VE Ticaret AS
Fetih Mahallesi Mahir Sokak No:5/201 Karatay
Konya,  TR 42030
Applicant Contact Muhammed Hulusi Sonmez
Correspondent
Imicryl Dis Malzemeleri Sanayi VE Ticaret AS
Fetih Mahallesi Mahir Sokak No:5/201 Karatay
Konya,  TR 42030
Correspondent Contact Husamettin Sonmez
Regulation Number872.3200
Classification Product Code
KLE  
Date Received10/15/2019
Decision Date 01/19/2021
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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