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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 K241391
Device Name Straumann® PURE Ceramic Implants
Applicant
Institut Straumann AG
Peter Merian Weg 12
Basel,  CH CH-4002
Applicant Contact Corinne Arimatea
Correspondent
Straumann USA, LLC
6 0 Minuteman Rd.
Andover,  MA  01810
Correspondent Contact Jennifer Jackson
Regulation Number872.3640
Classification Product Code
DZE  
Date Received05/15/2024
Decision Date 12/10/2024
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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