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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 K251188
Device Name UNIQA® Dental Implants System
Applicant
Uniqa Dental, Ltd.
2 Ha-Tsoran St.
Netanya,  IL 4250602
Applicant Contact Dima Goberman
Correspondent
Sterling Medical Registration
22750 Califa Street
Woodland Hills,  CA  91367
Correspondent Contact Daniela Levy
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received04/17/2025
Decision Date 06/25/2026
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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