FDA 510(k) Application Details - K231990

Device Classification Name Locator, Root Apex

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510(K) Number K231990
Device Name Locator, Root Apex
Applicant Cefla S.C.
Via Selice Provinciale N.23/A
Imola 40026 IT
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Contact Daidone Simona
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Regulation Number 000.0000

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Classification Product Code LQY
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Date Received 07/05/2023
Decision Date 02/13/2024
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K231990


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