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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Aligner, Sequential
510(k) Number K222418
Device Name Nuvola
Applicant
Gruppo Europeo Ortodonzia Srl
Via Cropani, 118 A/B
Rome,  IT 00173
Applicant Contact Massimiliano Bucceri
Correspondent
Donawa Lifescience Consulting Srl
Piazza Albania 10
Rome,  IT 00153
Correspondent Contact Carlo d`Alessandro
Regulation Number872.5470
Classification Product Code
NXC  
Date Received08/10/2022
Decision Date 10/07/2022
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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