Y-Kelin

Primary DI
06943566100095
Brand
Y-Kelin
Company
ANHUI GREENLAND BIOTECH CO.,LTD
Model
30 pads
Device description
Products Name: Y-Kelin Denture Adhesive Cushion for Upper DenturesSpecification: 30 piecesComposition: Sodium alginate, Polyester fiber, Viscose fiberApplicable People: For complete dentures.Products Features: Increase the absorbability of the removable denture and the alveolar ridge. Extra strong secure hold. Does not affect taste.Directions:1. Clean and moisten the dentures.2.If the cushion is too large, cut the cushion to appropriate with scissor, keep in mind that leaving the denture margin of 2mm, Do not cover. 3. Moisten the adhesive cushion in warm water, place and press it on the denture. Press the cushion with two thumbs from the denture center to the sides, until the cushion is completely flat docile.4 . Place dentures into mouth. Hold firmly until secure. Caution: If irritation occurs, discontinue use. The products can not be resued. Keep out of reach of children. Allergy caution.Store: A dark and dry place.Expiry date: in 36 months
Published
2019-04-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
EHSCushion, Denture, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EHSCushion, Denture, Over The CounterDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06943566100637PackageGS12In Commercial Distribution
06943566100095PrimaryGS10
6943566100095Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06943566100637069435661006376943566100637
06943566100095069435661000956943566100095

GMDN Terms#

Term, Definition table
TermDefinition
Denture cushionA prefabricated device intended to be used to improve the fit of a loose or ill-fitting (uncomfortable) denture. It is typically self-applied by a patient in the home and serves as a temporary measure until replacement dentures are made. After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity0 Percent (%) Relative Humidity40 Percent (%) Relative Humidity
Handling Environment Temperature15 Degrees Celsius30 Degrees Celsius
Storage Environment Humidity0 Percent (%) Relative Humidity40 Percent (%) Relative Humidity
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Regulatory Flags#

DUNS number
544396491
Device count
30
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06943566100163Y-Kelin30 pads2019-04-19
06943566100118Y-Kelin30 Tablets2022-12-06
06943566107391Y-Kelin36 Tablets2022-12-06
16943566100115Y-Kelin30 Tablets2022-12-06
06943566100187Y-Kelin40g/Box2022-12-06
06943566100378Y-Kelin25g/Box2022-12-06
06943566100514Y-Kelin12 Tablets2022-12-06
16943566107398Y-Kelin36 Tablets2022-12-06
06943566100651Y-Kelinupper 30 pads + lower 30 pads2019-04-19
06943566100637Y-Kelin30 pads2019-04-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06943566100163Y-KelinANHUI GREENLAND BIOTECH CO.,LTDEHS2019-04-19
06943566100651Y-KelinANHUI GREENLAND BIOTECH CO.,LTDEHS2019-04-19
06943566100637Y-KelinANHUI GREENLAND BIOTECH CO.,LTDEHS2019-04-15