Aerodentis System

Aligner, Sequential

Dror Orthodesign

The following data is part of a premarket notification filed by Dror Orthodesign with the FDA for Aerodentis System.

Pre-market Notification Details

Device IDK192069
510k NumberK192069
Device Name:Aerodentis System
ClassificationAligner, Sequential
Applicant Dror Orthodesign 7 Hartom St., Mount Hotzvim Jerusalem,  IL 9777507
ContactMichael Nadav
CorrespondentJanice M. Hogan
Hogan Lovelle US LLP 1735 Market Street, Suite 2300 Philadelphia,  PA  19103
Product CodeNXC  
CFR Regulation Number872.5470 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-08-01
Decision Date2020-05-06

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