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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 K151324
FOIA Releasable 510(k) K151324
Device Name Straumann Variobase for CEREC
Applicant
Straumann USA, LLC
60 Minuteman Rd.
Andover,  MA  01810
Applicant Contact Christopher Klaczyk
Correspondent
Heyer Regulatory Solutions, LLC
125 Cherry Ln.
Amherst,  MA  01002
Correspondent Contact Sheila Hemeon-Heyer
Regulation Number872.3630
Classification Product Code
NHA  
Date Received05/18/2015
Decision Date 09/11/2015
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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