DESS Dental Smart Solutions

Abutment, Implant, Dental, Endosseous

Terrats Medical SL

The following data is part of a premarket notification filed by Terrats Medical Sl with the FDA for Dess Dental Smart Solutions.

Pre-market Notification Details

Device IDK191986
501k NumberK191986
Device Name:DESS Dental Smart Solutions
ClassificationAbutment, Implant, Dental, Endosseous
Applicant Terrats Medical SL Carrer Mogoda 75-99 Barbera Del Valles,  ES 08210
ContactRoger Terrats
CorrespondentFloyd G. Larson
PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego,  CA  92130
Product CodeNHA  
CFR Regulation Number872.3630 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyDental
501k Review PanelDental
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-07-25
Decision Date2019-11-10

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