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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 K231210
Device Name DGA Abutment
Applicant
Modern Dental Laboratory (Dg) Co., Ltd.
Rm. 102&1102&Floor 4-10,Block 1 Modern Dental Industrial
Park, # 7 Nantou, Songshan Lake
Dongguan,  CN 523000
Applicant Contact Robin Liu
Correspondent
Modern Dental Laboratory (Dg) Co., Ltd.
Rm. 102&1102&Floor 4-10,Block 1 Modern Dental Industrial
Park, # 7 Nantou, Songshan Lake
Dongguan,  CN 523000
Correspondent Contact Robin Liu
Regulation Number872.3630
Classification Product Code
NHA  
Date Received04/27/2023
Decision Date 03/05/2024
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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