eCligner®

GUDID 38800018800035

1. Description eCligner® is thin, transparent and removable orthodontic aligner. 2. Explanation 2.1 eCligner®, developed by 3D digital technology e

E-Clear International Co., Ltd.

Orthodontic appliance system, progressive
Primary Device ID38800018800035
NIH Device Record Keyedad7899-2440-43f3-a5da-5cbe2a9e0762
Commercial Distribution StatusIn Commercial Distribution
Brand NameeCligner®
Version Model Number1.0
Company DUNS557822613
Company NameE-Clear International Co., Ltd.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-888-400-2651
Emailusa@ecligner.com
Phone1-888-400-2651
Emailusa@ecligner.com
Phone1-888-400-2651
Emailusa@ecligner.com
Phone1-888-400-2651
Emailusa@ecligner.com
Phone1-888-400-2651
Emailusa@ecligner.com
Phone1-888-400-2651
Emailusa@ecligner.com
Phone1-888-400-2651
Emailusa@ecligner.com
Phone1-888-400-2651
Emailusa@ecligner.com
Phone1-888-400-2651
Emailusa@ecligner.com
Phone1-888-400-2651
Emailusa@ecligner.com
Phone1-888-400-2651
Emailusa@ecligner.com

Device Identifiers

Device Issuing AgencyDevice ID
GS118800018800017 [Primary]
GS118800018800116 [Package]
Contains: 18800018800017
Package: PAPER CASE [3 Units]
Discontinued: 2016-09-23
Not in Commercial Distribution
GS118800018800215 [Package]
Contains: 18800018800017
Package: PAPER CASE [6 Units]
Discontinued: 2016-09-23
Not in Commercial Distribution
GS118800018800314 [Package]
Contains: 18800018800017
Package: PAPER CASE [9 Units]
Discontinued: 2016-09-23
Not in Commercial Distribution
GS118800018800413 [Package]
Contains: 18800018800017
Package: PAPER CASE [12 Units]
Discontinued: 2016-09-23
Not in Commercial Distribution
GS118800018800512 [Package]
Contains: 18800018800017
Package: PAPER CASE [15 Units]
Discontinued: 2016-09-23
Not in Commercial Distribution
GS118800018800611 [Package]
Contains: 18800018800017
Package: PAPER CASE [18 Units]
Discontinued: 2016-09-23
Not in Commercial Distribution
GS118800018800710 [Package]
Contains: 18800018800017
Package: PAPER CASE [21 Units]
Discontinued: 2016-09-23
Not in Commercial Distribution
GS118800018800819 [Package]
Contains: 18800018800017
Package: PAPER CASE [24 Units]
Discontinued: 2016-09-23
Not in Commercial Distribution
GS118800018800918 [Package]
Contains: 18800018800017
Package: PAPER CASE [27 Units]
Discontinued: 2016-09-23
Not in Commercial Distribution
GS128800018800014 [Package]
Contains: 18800018800918
Package: Carton Box Small [1 Units]
Discontinued: 2016-09-23
Not in Commercial Distribution
GS128800018800021 [Package]
Contains: 18800018800918
Package: Carton Box Small [2 Units]
Discontinued: 2016-09-23
Not in Commercial Distribution
GS138800018800028 [Package]
Contains: 18800018800918
Package: Carton Box Big [2 Units]
Discontinued: 2016-09-23
Not in Commercial Distribution
GS138800018800035 [Package]
Contains: 18800018800918
Package: Carton Box Big [3 Units]
Discontinued: 2016-09-23
Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HJDIlluminator, Color Vision Plate

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-23

Trademark Results [eCligner]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ECLIGNER
ECLIGNER
85250444 4155130 Dead/Cancelled
Kim, Tae-Weon
2011-02-24
ECLIGNER
ECLIGNER
79192161 5268350 Live/Registered
E-CLEARINTERNATIONAL CO., LTD.
2016-03-21

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.