FDA 510(k) Application Details - K231210

Device Classification Name Abutment, Implant, Dental, Endosseous

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510(K) Number K231210
Device Name Abutment, Implant, Dental, Endosseous
Applicant Modern Dental Laboratory (DG) Co., Ltd.
Room 102&1102&Floor 4-10,Block 1 Modern Dental Industrial
Park, No.7 Nantou, Songshan Lake
Dongguan 523000 CN
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Contact Robin Liu
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Regulation Number 872.3630

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Classification Product Code NHA
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Date Received 04/27/2023
Decision Date 03/05/2024
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K231210


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