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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
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