eCligner®
Basic Information
- Brand Name
- eCligner®
- Primary DI
- 18800018800017
- Version / Model
- 1.0
- Company Name
- E-Clear International Co., Ltd.
- Labeler DUNS
- 557822613
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 4
- Public Version Date
- 2021-02-05
- Public Version Status
- Update
- Public Device Record Key
- edad7899-2440-43f3-a5da-5cbe2a9e0762
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
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HJD | Illuminator, Color Vision Plate | Ophthalmic | 886.1160 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 38800018800035 | GS1 | Carton Box Big | 3 | Not in Commercial Distribution | 2016-09-23 |
| Package | 18800018800918 | GS1 | PAPER CASE | 27 | Not in Commercial Distribution | 2016-09-23 |
| Primary | 18800018800017 | GS1 | ||||
| Package | 38800018800028 | GS1 | Carton Box Big | 2 | Not in Commercial Distribution | 2016-09-23 |
| Package | 28800018800021 | GS1 | Carton Box Small | 2 | Not in Commercial Distribution | 2016-09-23 |
| Package | 18800018800116 | GS1 | PAPER CASE | 3 | Not in Commercial Distribution | 2016-09-23 |
| Package | 18800018800215 | GS1 | PAPER CASE | 6 | Not in Commercial Distribution | 2016-09-23 |
| Package | 18800018800314 | GS1 | PAPER CASE | 9 | Not in Commercial Distribution | 2016-09-23 |
| Package | 18800018800413 | GS1 | PAPER CASE | 12 | Not in Commercial Distribution | 2016-09-23 |
| Package | 18800018800512 | GS1 | PAPER CASE | 15 | Not in Commercial Distribution | 2016-09-23 |
| Package | 18800018800611 | GS1 | PAPER CASE | 18 | Not in Commercial Distribution | 2016-09-23 |
| Package | 18800018800710 | GS1 | PAPER CASE | 21 | Not in Commercial Distribution | 2016-09-23 |
| Package | 18800018800819 | GS1 | PAPER CASE | 24 | Not in Commercial Distribution | 2016-09-23 |
| Package | 28800018800014 | GS1 | Carton Box Small | 1 | Not in Commercial Distribution | 2016-09-23 |
Customer Contacts
- Phone
- 1-888-400-2651
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K143499 | 000 |