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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 K130462
Device Name PALTOP NARROW IMPLANT, PALTOP SHORT IMPLANT
Applicant
Paltop Advanced Dental Solutions, Ltd.
5 Hashita St.
P.O. Box 3568
Caesarea,  IL IS
Applicant Contact TAL HAMMER-TOPAZ
Correspondent
Paltop Advanced Dental Solutions, Ltd.
5 Hashita St.
P.O. Box 3568
Caesarea,  IL IS
Correspondent Contact TAL HAMMER-TOPAZ
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received02/22/2013
Decision Date 08/27/2013
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
Recalls CDRH Recalls
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