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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, orthodontic
510(k) Number K040469
Device Name THE STRAUMANN ORTHO IMPLANT SYSTEM
Applicant
THE STRAUMANN CO.
RESERVOIR PL. 1601 TRAPELO RD.
WALTHAM,  MA  02451
Applicant Contact CAROLYN BITETTI
Correspondent
THE STRAUMANN CO.
RESERVOIR PL. 1601 TRAPELO RD.
WALTHAM,  MA  02451
Correspondent Contact CAROLYN BITETTI
Regulation Number872.3640
Classification Product Code
OAT  
Date Received02/24/2004
Decision Date 04/30/2004
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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