Y-Kelin

Primary DI
06943566100637
Brand
Y-Kelin
Company
ANHUI GREENLAND BIOTECH CO.,LTD
Model
30 pads
Device description
Products Name: Y-Kelin Denture Adhesive Cushion for Upper Dentures Specification: 30 pieces Composition: Vicose Fiber, Alginate. Applicable 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: Applying: 1. Overlap cushion with the denture and trim to fit; 2. Lightly soak the cushion with water and press it into denture; 3. Wear denture and bite down with rocking motion for 15 seconds.. Removing: 1. If you have trouble removing, swish some warm water; 2. Slowly remove denture using a rocking motion; 3. Remove the cushion completely and clean with denture brush and soak in cleansing tablet solution until next use. Adverse reactions: Isolated cases of hypersensitivity reactions in the mucous membranes of the mouth. Please consult a medical professional. Contraindications: Hypersensitivity to one of the ingredients. 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: 3 years
Published
2019-04-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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 used to improve the fit of a loose or ill-fitting (uncomfortable) denture. It serves as a temporary measure until replacement dentures are made, and is available [non-prescription] over-the-counter (OTC). 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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
544396491
Device count
30
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
06943566100095Y-Kelin30 pads2019-04-15
06943566100651Y-Kelinupper 30 pads + lower 30 pads2019-04-19

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
06943566100095Y-KelinANHUI GREENLAND BIOTECH CO.,LTDEHS2019-04-15