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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 K040539
Device Name ELLIPTIC MATRIX
Applicant
Institut Straumann AG
Reservoir Pl. 1601 Trapelo Rd.
Waltham,  MA  02451
Applicant Contact JOHN KING
Correspondent
Institut Straumann AG
Reservoir Pl. 1601 Trapelo Rd.
Waltham,  MA  02451
Correspondent Contact JOHN KING
Regulation Number872.3630
Classification Product Code
NHA  
Date Received03/02/2004
Decision Date 03/18/2004
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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