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 Orthodontic appliance system, progressive Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner

• 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