Elos Accurate Hybrid Base

Abutment, Implant, Dental, Endosseous

Elos Medtech Pinol A/S

The following data is part of a premarket notification filed by Elos Medtech Pinol A/s with the FDA for Elos Accurate Hybrid Base.

Pre-market Notification Details

Device IDK191919
510k NumberK191919
Device Name:Elos Accurate Hybrid Base
ClassificationAbutment, Implant, Dental, Endosseous
Applicant Elos Medtech Pinol A/S Engvej 33 Gorlose,  DK Dk-3330
ContactTina Friis Poulsen
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)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-07-18
Decision Date2020-02-10

NIH GUDID Devices

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