AccessGUDID - DEVICE: eCligner® (18800018800017)

GUDID

Device Identifier (DI) Information

Brand Name: eCligner®
Version or Model: 1.0
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: E-Clear International Co., Ltd.

Primary DI Number: 18800018800017
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 557822613 *Terms of Use

Device Description: 1. Description eCligner® is thin, transparent and removable orthodontic aligner. 2. Explanation 2.1 eCligner®, developed by 3D digital technology eCligner® is clear aligner made by 3D digital CAD/CAM system. Self-developed 3D simulation program is yearly upgraded with latest technology. All that’s needed to make whole set of eCligner® for patient is only one stone model. 2.2 eCligner® provides aesthetic and comfortable orthodontic treatment. Transparent aligner won’t be noticed by others and can temporarily be removed at one’s convenience. Recommended aligner wear time is 17 hours daily for the best treatment result. 2.3 eCligner® system process eCligner® has combined dental orthodontic concept and principles into 3D simulation system. Orthodontic professionals produce aligners based on such system, calibrating teeth movement and influences that affect teeth and even tissues. 1) eCligner® aligners consists of 3 aligners per step. (Patient should wear Soft,Medium,Hard aligners for a week each) 2) Patient should wear each aligners 17~19 hours daily. 3) Aligner enables gradual teeth movement per each step. 4) Advise patient to visit your clinic and check treatment progress every 3 weeks

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
44738	Orthodontic progressive aligner	A custom-made orthodontic appliance, typically supplied in series intended to be worn in succession and self-changed every few weeks, designed to influence the shape and/or function of the stomatognathic system to correct malocclusions (e.g., underbites, overbites, cross bites, open bites, crooked teeth) and/or other cosmetic and/or structural flaws of teeth and/or jaws. Also described as sequential or successive, the device is custom-made based on an oral impression, self-removable, and is typically made of clear/transparent synthetic polymers (e.g., a thermoformed polycarbonate); a post-treatment orthodontic retainer/positioner may be included with the device. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HJD	Illuminator, Color Vision Plate

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K143499	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: edad7899-2440-43f3-a5da-5cbe2a9e0762
Public Version Date: February 05, 2021
Public Version Number: 4
DI Record Publish Date: September 23, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
38800018800035	3	18800018800918	2016-09-23	Not in Commercial Distribution	Carton Box Big
18800018800918	27	18800018800017	2016-09-23	Not in Commercial Distribution	PAPER CASE
38800018800028	2	18800018800918	2016-09-23	Not in Commercial Distribution	Carton Box Big
28800018800021	2	18800018800918	2016-09-23	Not in Commercial Distribution	Carton Box Small
18800018800116	3	18800018800017	2016-09-23	Not in Commercial Distribution	PAPER CASE
18800018800215	6	18800018800017	2016-09-23	Not in Commercial Distribution	PAPER CASE
18800018800314	9	18800018800017	2016-09-23	Not in Commercial Distribution	PAPER CASE
18800018800413	12	18800018800017	2016-09-23	Not in Commercial Distribution	PAPER CASE
18800018800512	15	18800018800017	2016-09-23	Not in Commercial Distribution	PAPER CASE
18800018800611	18	18800018800017	2016-09-23	Not in Commercial Distribution	PAPER CASE
18800018800710	21	18800018800017	2016-09-23	Not in Commercial Distribution	PAPER CASE
18800018800819	24	18800018800017	2016-09-23	Not in Commercial Distribution	PAPER CASE
28800018800014	1	18800018800918	2016-09-23	Not in Commercial Distribution	Carton Box Small