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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Intraosseous
510(k) Number K050515
Device Name BONE BLOCK FIXATION SET
Applicant
Straumann USA, Inc.
1601 Trapelo Rd.
Waltham,  MA  02451
Applicant Contact LINDA JALBERT
Correspondent
Straumann USA, Inc.
1601 Trapelo Rd.
Waltham,  MA  02451
Correspondent Contact LINDA JALBERT
Regulation Number872.4880
Classification Product Code
DZL  
Date Received03/01/2005
Decision Date 04/05/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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