FDA 510(k) Application Details - K232383

Device Classification Name Abutment, Implant, Dental, Endosseous

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510(K) Number K232383
Device Name Abutment, Implant, Dental, Endosseous
Applicant Euroteknika
726 Rue Du General De Gaulle
Sallanches 74700 FR
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Contact Yoann Delatre
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Regulation Number 872.3630

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Classification Product Code NHA
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Date Received 08/08/2023
Decision Date 03/04/2025
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 K232383


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