AccessGUDID - DEVICE: Y-Kelin (06943566100651)

GUDID

Device Identifier (DI) Information

Brand Name: Y-Kelin
Version or Model: upper 30 pads + lower 30 pads
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ANHUI GREENLAND BIOTECH CO.,LTD

Primary DI Number: 06943566100651
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 60
Labeler D-U-N-S® Number*: 544396491 *Terms of Use

Device Description: Products Name: Y-Kelin Denture Adhesive Cushion Upper 30 pad + Lower 30 pads Specification: Upper 30 pieces/box + Lower 30 pieces/box Composition: Sodium alginate, Polyester fiber, Viscose fiber. 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: 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

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:	No
Prescription Use (Rx):	No
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?
11170	Denture cushion	A 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EHS	Cushion, Denture, Over The Counter

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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
Handling Environment Temperature: between 15 and 30 Degrees Celsius
Handling Environment Humidity: between 0 and 40 Percent (%) Relative Humidity
Storage Environment Temperature: between 15 and 30 Degrees Celsius
Storage Environment Humidity: between 0 and 40 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c4a52ed5-39b9-4519-96ed-408e4ce5b831
Public Version Date: November 24, 2022
Public Version Number: 3
DI Record Publish Date: April 19, 2019