Home GUDID 38800018800035 eCligner®
Primary DI 38800018800035
Brand eCligner®
Company E-Clear International Co., Ltd.
Model 1.0
Device description 1. Description eCligner® is thin, transparent and removable orthodontic aligner. 2. Explanation 2.1 eCligner®, developed by 3D digital technology e
Published 2016-09-23
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use true Product Codes# Code, Name table Code Name HJD Illuminator, Color Vision Plate
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HJD Illuminator, Color Vision Plate Ophthalmic 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 18800018800116 Package GS1 3 Not in Commercial Distribution 18800018800215 Package GS1 6 Not in Commercial Distribution 18800018800314 Package GS1 9 Not in Commercial Distribution 18800018800413 Package GS1 12 Not in Commercial Distribution 18800018800512 Package GS1 15 Not in Commercial Distribution 18800018800611 Package GS1 18 Not in Commercial Distribution 18800018800710 Package GS1 21 Not in Commercial Distribution 18800018800819 Package GS1 24 Not in Commercial Distribution 18800018800918 Package GS1 27 Not in Commercial Distribution 28800018800014 Package GS1 1 Not in Commercial Distribution 28800018800021 Package GS1 2 Not in Commercial Distribution 38800018800028 Package GS1 2 Not in Commercial Distribution 38800018800035 Package GS1 3 Not in Commercial Distribution 18800018800017 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 18800018800116 18800018800116 18800018800215 18800018800215 18800018800314 18800018800314 18800018800413 18800018800413 18800018800512 18800018800512 18800018800611 18800018800611 18800018800710 18800018800710 18800018800819 18800018800819 18800018800918 18800018800918 28800018800014 28800018800014 28800018800021 28800018800021 38800018800028 38800018800028 38800018800035 38800018800035 18800018800017 18800018800017
GMDN Terms# Term, Definition table Term Definition Orthodontic appliance system, progressive A series of preformed teeth aligners or positioners, worn in succession and changed every few weeks, designed to influence the shape and/or function of the stomatognathic system; often used to impact a patient's appearance and self image. It is typically custom-made using computer-generated modelling based on an initial oral impression, and a consultation with an orthodontist. It is typically made of a clear hard plastic, e.g., a thermoformed polycarbonate (PC). It is typically used to correct malocclusions such as underbites, overbites, cross bites and open bites, or crooked teeth and various other flaws of teeth and jaws, whether cosmetic or structural. This is a single-use device.
Regulatory Flags# DUNS number 557822613 Device count 1 DM exempt true Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label true Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 18800018800017 eCligner® 1.0 2016-09-23
Other Devices Sharing Product Codes# 
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