Y-Kelin
Basic Information
- Brand Name
- Y-Kelin
- Primary DI
- 06943566100378
- Version / Model
- 25g/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
- c02c350b-371c-4b73-bfc4-5834d26af9d3
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
- 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 |
|---|---|---|---|---|
| KOQ | Adhesive, Denture, Carboxymethylcellulose Sodium (40-100&) | Dental | 872.3410 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06943566100378 | GS1 |