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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 K183391
Device Name Novidia Universal Bond
Applicant
Nobio , Ltd.
8 Hamatechet St.
Kadima,  IL 6092000
Applicant Contact Inbal Beinglass Peled
Correspondent
Nobio [C/O Promedoss, Inc.]
3521 Hatwynn Rd.
Charlott,  NC  28269
Correspondent Contact Shoshana (Shosh) Friedman
Regulation Number872.3200
Classification Product Code
KLE  
Date Received12/07/2018
Decision Date 09/24/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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