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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name abutment, implant, dental, endosseous
510(k) Number K101465
Device Name STRAUMANN CARES BRIDGE; STRAUMANN CARES DOLDER BAR
Applicant
INSTITUT STRAUMANN AG
60 MINUTEMAN ROAD
ANDOVER,  MA  01810
Applicant Contact JANET KAY
Correspondent
INSTITUT STRAUMANN AG
60 MINUTEMAN ROAD
ANDOVER,  MA  01810
Correspondent Contact JANET KAY
Regulation Number872.3630
Classification Product Code
NHA  
Date Received05/26/2010
Decision Date 12/13/2010
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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