Y-Kelin
Basic Information
- Brand Name
- Y-Kelin
- Primary DI
- 06943566100187
- Version / Model
- 40g/Box
- Company Name
- ANHUI GREENLAND BIOTECH CO.,LTD
- Labeler DUNS
- 544396491
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-06
- Public Version
- 1
- Public Version Date
- 2022-12-14
- Public Version Status
- New
- Public Device Record Key
- 3c43daf1-3fa4-4995-a796-c41e2be6f969
Device Description
Product Name: Y-kelin Adhesive Cream for Upper and Lower Dentures. Specification:40g. Main Ingredient: Calcium Sodium PVM/MA Copolymer, Carboxymethyl cellulose,Methyl-p-hydroxy benzoate, Vaseline, Paraffin, Silica, Menthol, Azorubin.Does not contain Zinc. Applicable People: For complete dentures. Directions: 1.Clean and dry your dentures thoroughly. 2.Apply the cream to either wet or dry dentures. 3.Squeeze the cream from the bottcom of the tube. It is better to flatten the tube and not roil it. 4. Apply the cream to your dentures in strips (as shown in the diagram) or series of dots, making sure that the cream is not too close to the edge of the denture. 5.Insert denture into mouth and bite firmly. 6. For best results wait 15 minutes, before eating or drinking Expiry date: in 36 months.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KOT | Carboxymethylcellulose Sodium Or Polyvinyl Methylether Maleic Acid Calcium-Sodium | Dental | 872.3490 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46124 | Karaya/acacia denture adhesive, high sodium borate | An adhesive compound composed of karaya, with or without acacia (fine vegetable gum powders), and sodium borate (typically more than 12% by weight), 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06943566100187 | GS1 |