eCligner®

Primary DI
18800018800017
Brand
eCligner®
Company
E-Clear International Co., Ltd.
Model
1.0
Device description
1. DescriptioneCligner® 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
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HJDIlluminator, Color Vision Plate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HJDIlluminator, Color Vision PlateOphthalmic1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K143499000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K143499000eClignerEclear International Co., Ltd.2015-10-09NXC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18800018800116PackageGS13Not in Commercial Distribution
18800018800215PackageGS16Not in Commercial Distribution
18800018800314PackageGS19Not in Commercial Distribution
18800018800413PackageGS112Not in Commercial Distribution
18800018800512PackageGS115Not in Commercial Distribution
18800018800611PackageGS118Not in Commercial Distribution
18800018800710PackageGS121Not in Commercial Distribution
18800018800819PackageGS124Not in Commercial Distribution
18800018800918PackageGS127Not in Commercial Distribution
28800018800014PackageGS11Not in Commercial Distribution
28800018800021PackageGS12Not in Commercial Distribution
38800018800028PackageGS12Not in Commercial Distribution
38800018800035PackageGS13Not in Commercial Distribution
18800018800017PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1880001880011618800018800116
1880001880021518800018800215
1880001880031418800018800314
1880001880041318800018800413
1880001880051218800018800512
1880001880061118800018800611
1880001880071018800018800710
1880001880081918800018800819
1880001880091818800018800918
2880001880001428800018800014
2880001880002128800018800021
3880001880002838800018800028
3880001880003538800018800035
1880001880001718800018800017

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic progressive alignerA 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.

Contacts#

Phone, Email table
PhoneEmail
1-888-400-2651usa@ecligner.com

Regulatory Flags#

DUNS number
557822613
Device count
1
DM exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
38800018800035eCligner®1.02016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327084078NAStryker GmbHHJD2018-09-24
04712568360712EOSNORTH EOS INDUSTRIES INC.HJD2018-08-15
04712568360880EOSNORTH EOS INDUSTRIES INC.HJD2018-08-15
38800018800035eCligner®E-Clear International Co., Ltd.HJD2016-09-23