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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 K253999
Device Name Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC; Temporary Abutment Engaging and Non-Engaging; Healing Abutment Conical Connection; Omnigrip Clinical Screw Titanium; Omnigrip Prosthetic Screw
Applicant
Nobel Biocare AB
Vastra Hamngatan 1
Goteborg,  SE SE 411 17
Applicant Contact Bernice Jim
Correspondent
Nobel Biocare AB
Vastra Hamngatan 1
Goteborg,  SE SE 411 17
Correspondent Contact Bernice Jim
Regulation Number872.3630
Classification Product Code
NHA  
Subsequent Product Code
PNP  
Date Received12/15/2025
Decision Date 08/06/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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