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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, Root-Form
510(k) Number K210523
Device Name Implanova
Applicant
Dental Evolutions, Inc.
9100 Wilshire Blvd. Suite 448w
Beverly Hills,  CA  90212
Applicant Contact Matthew Mineros
Correspondent
Arazy Group
3422 Leonardo Ln.
New Smyrna,  FL  32168
Correspondent Contact Raymond Kelly
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received02/23/2021
Decision Date 09/30/2021
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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