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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 K040807
Device Name MIS DENTAL IMPLANT SYSTEM
Applicant
Mis - Implant Technologies , Ltd.
278 Broadway
Elmwood Park,  NJ  07407
Applicant Contact MOTTI WEISMAN
Correspondent
Mis - Implant Technologies , Ltd.
278 Broadway
Elmwood Park,  NJ  07407
Correspondent Contact MOTTI WEISMAN
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received03/29/2004
Decision Date 06/09/2004
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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