Tri Auto ZX2

Handpiece, Direct Drive, Ac-powered

J. MORITA USA, INC.

The following data is part of a premarket notification filed by J. Morita Usa, Inc. with the FDA for Tri Auto Zx2.

Pre-market Notification Details

Device IDK170275
510k NumberK170275
Device Name:Tri Auto ZX2
ClassificationHandpiece, Direct Drive, Ac-powered
Applicant J. MORITA USA, INC. 9 MASON Irvine,  CA  92618
ContactKeisuke Mori
CorrespondentKeith A. Barritt
FISH & RICHARDSON P.C. 901 15th, St N.W SUITE 700 Washington Dc,  DC  20005
Product CodeEKX  
CFR Regulation Number872.4200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-01-30
Decision Date2017-09-11
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04548213055999 K170275 000

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