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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Locator, Root Apex
510(k) Number K231990
Device Name Apex Locator
Applicant
Cefla S.C.
Via Selice Provinciale N.23/A
Imola,  IT 40026
Applicant Contact Daidone Simona
Correspondent
Cefla S.C.
Via Selice Provinciale N.23/A
Imola,  IT 40026
Correspondent Contact Daidone Simona
Classification Product Code
LQY  
Date Received07/05/2023
Decision Date 02/13/2024
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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