FDA 510(k) Application Details - K240837

Device Classification Name Implant, Endosseous, Root-Form

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510(K) Number K240837
Device Name Implant, Endosseous, Root-Form
Applicant RDJ TOV Implant Ltd
Mutsafi St 8/4 View Tower
Jerusalem 96420 IL
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Contact David Elkouby
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Regulation Number 872.3640

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Classification Product Code DZE
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Date Received 03/27/2024
Decision Date 08/15/2024
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 K240837


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