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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laser, Dental, Soft Tissue
510(k) Number K213658
Device Name DEKA SMARTPERIO
Applicant
El.En Electronic Engineering Spa
Via Baldanzese 17
Calenzano,  FL  50041
Applicant Contact Paolo Peruzzi
Correspondent
El.En Electronic Engineering Spa
Via Baldanzese 17
Calenzano,  FL  50041
Correspondent Contact Paolo Peruzzi
Regulation Number878.4810
Classification Product Code
NVK  
Subsequent Product Code
GEX  
Date Received11/19/2021
Decision Date 03/11/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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