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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 K982509
Device Name ORTHO IMPLANT AND ACCESSORIES
Applicant
STRAUMANN USA
RESERVOIR PLACE,
1601 TRAPELO ROAD
WALTHAM,  MA  02154
Applicant Contact LINDA JALBERT
Correspondent
STRAUMANN USA
RESERVOIR PLACE,
1601 TRAPELO ROAD
WALTHAM,  MA  02154
Correspondent Contact LINDA JALBERT
Regulation Number872.3640
Classification Product Code
OAT  
Date Received07/20/1998
Decision Date 09/30/1998
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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