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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, Root-Form
510(k) Number K202942
Device Name Straumann 4 mm Short Implants
Applicant
Straumann USA, LLC
60 Minuteman Rd.
Andover,  MA  01810
Applicant Contact Chanrasmey N. White
Correspondent
Straumann USA, Lls
60 Minuteman Rd.
Andover,  MA  01801
Correspondent Contact Jennifer M. Jackson
Regulation Number872.3640
Classification Product Code
DZE  
Date Received09/30/2020
Decision Date 02/08/2021
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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