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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 K254145
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 Joseph Azary
Regulation Number872.3630
Classification Product Code
NHA  
Date Received12/22/2025
Decision Date 06/11/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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