Elos Accurate Customized Abutment

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 Customized Abutment.

Pre-market Notification Details

Device IDK191890
510k NumberK191890
Device Name:Elos Accurate Customized Abutment
ClassificationAbutment, Implant, Dental, Endosseous
Applicant Elos Medtech Pinol A/S Engvej 33 Goerloese,  DK Dk-3330
ContactTina Friis Poulsen
CorrespondentTina Friis Poulsen
Elos Medtech Pinol A/S Engvej 33 Goerloese,  DK Dk-3330
Product CodeNHA  
CFR Regulation Number872.3630 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyDental
510k Review PanelDental
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-07-15
Decision Date2020-02-06

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