FDA 510(k) Application Details - K231827

Device Classification Name Abutment, Implant, Dental, Endosseous

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510(K) Number K231827
Device Name Abutment, Implant, Dental, Endosseous
Applicant B.T.I. Biotechnology Institute, S.L.
Leonardo Da Vinci 14
Mi±ano 01510 ES
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Contact JosΘ Ram≤n Rivero
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Regulation Number 872.3630

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Classification Product Code NHA
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Date Received 06/21/2023
Decision Date 09/15/2023
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



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