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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implant, Endosseous, Root-Form
510(k) Number K192053
Device Name W Zirconia Implants
Applicant
Tav Medical , Ltd.
Dora Industrial Park, P.O. Box 88
Shlomi,  IL 2283202
Applicant Contact Revital Shabtai
Correspondent
Tav Medical , Ltd.
Dora Industrial Park, P.O. Box 88
Shlomi,  IL 2283202
Correspondent Contact Revital Shabtai
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received07/31/2019
Decision Date 10/29/2019
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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