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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implant, Endosseous, Orthodontic
510(k) Number K242944
Device Name Leone Orthodontic Implant TAD (Temporary Anchorage Device)
Applicant
Leone S.P.A.
Via P.A Quaracchi, 50
Sesto Fiorentino,  IT 50019
Applicant Contact Martina Corsani
Correspondent
ProMedic, LLC
131 Bay Pt. Dr. NE
St. Petersburg,  FL  33704
Correspondent Contact Paul Dryden
Regulation Number872.3640
Classification Product Code
OAT  
Date Received09/25/2024
Decision Date 06/19/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
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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