Lubrina 2

Handpiece, Air-powered, Dental

J. Mortia USA, Inc.

The following data is part of a premarket notification filed by J. Mortia Usa, Inc. with the FDA for Lubrina 2.

Pre-market Notification Details

Device IDK190509
510k NumberK190509
Device Name:Lubrina 2
ClassificationHandpiece, Air-powered, Dental
Applicant J. Mortia USA, Inc. 9 Mason Irvine,  CA  92618
ContactFujio Zushi
CorrespondentKeith A. Barritt
Fish & Richardson P.C. 1000 Maine Ave. S.W. 9th Floor Washington,  DC  20024
Product CodeEFB  
CFR Regulation Number872.4200 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyDental
510k Review PanelDental
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-03-01
Decision Date2020-03-04

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