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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 K242064
Device Name Omni-Directional Multi-unit Abutment System (Trade Name: Omnibut™)
Applicant
Smart Denture Conversions, LLC
1800 N. Salem St.
Suite 104
Apex,  NC  27523
Applicant Contact Derrik Conrad
Correspondent
Aztech Regulatory & Quality, LLC
543 Long Hill Ave.
Shelton,  CT  06484
Correspondent Contact Azary Joseph
Regulation Number872.3630
Classification Product Code
NHA  
Date Received07/15/2024
Decision Date 01/17/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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