FDA 510(k) Application Details - K222215

Device Classification Name Abutment, Implant, Dental, Endosseous

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510(K) Number K222215
Device Name Abutment, Implant, Dental, Endosseous
Applicant Implant Protesis Dental 2004 S.L
Cami del Mig. 71.
Mataro 08302 ES
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Contact Francesc Fumanal
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Regulation Number 872.3630

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Classification Product Code NHA
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Date Received 07/25/2022
Decision Date 10/21/2022
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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