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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 K150040
Device Name Implanova
Applicant
Dental Evolutions, Inc.
9100 Wilshire Blvd. Suite W448
Beverly Hills,  CA  90212
Applicant Contact PARSA T ZADEH
Correspondent
LK Consulting Group USA, Inc.
2651 E. Chapman Ave., Suite 110
Fullerton,  CA  92831
Correspondent Contact PRISCILLA CHUNG
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received01/09/2015
Decision Date 08/27/2015
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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