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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 K034067
Device Name ZTI IMPLANTS SYSTEM, DRM IMPLANTS
Applicant
DRM RESEARCH LABORATORIES, INC.
29 BUSINESS PARK DR.
BRANFORD,  CT  06405
Applicant Contact SAMUEL WAKNINE
Correspondent
DRM RESEARCH LABORATORIES, INC.
29 BUSINESS PARK DR.
BRANFORD,  CT  06405
Correspondent Contact SAMUEL WAKNINE
Regulation Number872.3640
Classification Product Code
DZE  
Date Received12/31/2003
Decision Date 03/08/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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