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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Impression
510(k) Number K935896
Device Name THIXOFLEX
Applicant
Zhermack Dental Production
Via Bovazecchino, 100
45021 Badia Polesine
(Rovigo) Italy,  IT
Applicant Contact MONICA MARTELLO
Correspondent
Zhermack Dental Production
Via Bovazecchino, 100
45021 Badia Polesine
(Rovigo) Italy,  IT
Correspondent Contact MONICA MARTELLO
Regulation Number872.3660
Classification Product Code
ELW  
Date Received10/12/1993
Decision Date 09/09/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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