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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Headgear, Extraoral, Orthodontic
510(k) Number K202855
Device Name Orthodontic Facemask
Applicant
Ita.O Italian Orthodontic System S.R.L.
Via Merighi, 30/3 - 30/4
Villanova Di Castenaso,  IT 40055
Applicant Contact Alessandra Ferroni
Correspondent
THEMA S.r.l.
Via Saragat 5
Imola,  IT 40026
Correspondent Contact Marisa Testa
Regulation Number872.5500
Classification Product Code
DZB  
Date Received09/28/2020
Decision Date 06/21/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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