AccessGUDID - DEVICE: Y-Kelin (06943566100378)

GUDID

Device Identifier (DI) Information

Brand Name: Y-Kelin
Version or Model: 25g/Box
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ANHUI GREENLAND BIOTECH CO.,LTD

Primary DI Number: 06943566100378
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 544396491 *Terms of Use

Device Description: Product Name:Y-kelin Denture Adhesive Powder. Composition: Sodium Alginate. Scope of applicable: Special denture adhesive, a temporary auxiliary denture retentive material. Product Features: Supper extra strength keeps dentures secure. Easy to use.No added colors and flavor,does not affect taste. Directions: 1.Clean and moisten your dentures thoroughly. 2.Tilt the powder bottle mouth towards the denture support, gently tap on the bottle body by index finger, then evenly spray the appropriate adhesive powder to the surface of the denture support. 3. Insert denture into mouth and bite firmly for several seconds. Applicable People: For complete dentures. Store: keep in cool and dry place. Specification: 25g Expiry date: in 24 months. Manufacturer: Anhui Greenland Biotech Co.,Ltd. Add: Mohekou Industrial Zone, Bengbu, Anhui, China. Tel:0552-5875300

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:	Yes
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?
46128	Karaya denture adhesive	An adhesive compound composed of karaya (a fine vegetable gum powder) used to stabilize a removable prosthesis in the mouth, particularly a denture, by adhering the prosthesis to the oral mucosa. The compound is typically applied to the base of a denture before it is inserted in the mouth. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KOQ	Adhesive, Denture, Carboxymethylcellulose Sodium (40-100&)

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c02c350b-371c-4b73-bfc4-5834d26af9d3
Public Version Date: December 14, 2022
Public Version Number: 1
DI Record Publish Date: December 06, 2022