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 ID: 38800018800035
• NIH Device Record Key: edad7899-2440-43f3-a5da-5cbe2a9e0762
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: eCligner®
• Version Model Number: 1.0
• Company DUNS: 557822613
• Company Name: E-Clear International Co., Ltd.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-888-400-2651
• Email: usa@ecligner.com
• Phone: 1-888-400-2651
• Email: usa@ecligner.com
• Phone: 1-888-400-2651
• Email: usa@ecligner.com
• Phone: 1-888-400-2651
• Email: usa@ecligner.com
• Phone: 1-888-400-2651
• Email: usa@ecligner.com
• Phone: 1-888-400-2651
• Email: usa@ecligner.com
• Phone: 1-888-400-2651
• Email: usa@ecligner.com
• Phone: 1-888-400-2651
• Email: usa@ecligner.com
• Phone: 1-888-400-2651
• Email: usa@ecligner.com
• Phone: 1-888-400-2651
• Email: usa@ecligner.com
• Phone: 1-888-400-2651
• Email: usa@ecligner.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	18800018800017 [Primary]
GS1	18800018800116 [Package]; Contains: 18800018800017; Package: PAPER CASE [3 Units]; Discontinued: 2016-09-23; Not in Commercial Distribution
GS1	18800018800215 [Package]; Contains: 18800018800017; Package: PAPER CASE [6 Units]; Discontinued: 2016-09-23; Not in Commercial Distribution
GS1	18800018800314 [Package]; Contains: 18800018800017; Package: PAPER CASE [9 Units]; Discontinued: 2016-09-23; Not in Commercial Distribution
GS1	18800018800413 [Package]; Contains: 18800018800017; Package: PAPER CASE [12 Units]; Discontinued: 2016-09-23; Not in Commercial Distribution
GS1	18800018800512 [Package]; Contains: 18800018800017; Package: PAPER CASE [15 Units]; Discontinued: 2016-09-23; Not in Commercial Distribution
GS1	18800018800611 [Package]; Contains: 18800018800017; Package: PAPER CASE [18 Units]; Discontinued: 2016-09-23; Not in Commercial Distribution
GS1	18800018800710 [Package]; Contains: 18800018800017; Package: PAPER CASE [21 Units]; Discontinued: 2016-09-23; Not in Commercial Distribution
GS1	18800018800819 [Package]; Contains: 18800018800017; Package: PAPER CASE [24 Units]; Discontinued: 2016-09-23; Not in Commercial Distribution
GS1	18800018800918 [Package]; Contains: 18800018800017; Package: PAPER CASE [27 Units]; Discontinued: 2016-09-23; Not in Commercial Distribution
GS1	28800018800014 [Package]; Contains: 18800018800918; Package: Carton Box Small [1 Units]; Discontinued: 2016-09-23; Not in Commercial Distribution
GS1	28800018800021 [Package]; Contains: 18800018800918; Package: Carton Box Small [2 Units]; Discontinued: 2016-09-23; Not in Commercial Distribution
GS1	38800018800028 [Package]; Contains: 18800018800918; Package: Carton Box Big [2 Units]; Discontinued: 2016-09-23; Not in Commercial Distribution
GS1	38800018800035 [Package]; Contains: 18800018800918; Package: Carton Box Big [3 Units]; Discontinued: 2016-09-23; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143499

FDA Product Code

• HJD: Illuminator, Color Vision Plate

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-23