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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 K233271
Device Name OsseOne Dental Implant System
Applicant
Synoross Dba Osseone
330 N Central Ave.
Glendale,  CA  91203
Applicant Contact Gennady Shapiro
Correspondent
Blackwell Device Consulting
P.O. Box 718
Gresham,  OR  97030
Correspondent Contact Angela Blackwell
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received09/29/2023
Decision Date 05/08/2025
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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