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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K173083
Device Name IMPLANTER DENTAL PLANNING SOFTWARE
Applicant
Implanter, LLC
2801 NE 183rd St.
#110w
Aventura,  FL  33160
Applicant Contact Jorge Millan
Correspondent
Implanter, LLC
7600 NW 69th Ave.
Medley,  FL  33166
Correspondent Contact Jorge Millan
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received09/29/2017
Decision Date 12/03/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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