Y-Kelin
Basic Information
- Brand Name
- Y-Kelin
- Primary DI
- 06943566100118
- Version / Model
- 30 Tablets
- Company Name
- ANHUI GREENLAND BIOTECH CO.,LTD
- Labeler DUNS
- 544396491
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 30
- 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
- 9814723d-cf11-4dab-8808-2e61c90360e9
Device Description
Product Name:Y-Kelin Denture Cleansing Tablet Features: Quickly dissolve and remove stains and plaques with the power of reactive oxygen. Keep dentures extra fresh and clean with minty flavor. Can be used for full dentures, partial dentures, removable retainers. Ingredients: Sodium Bicarbonate, Citric Acid, Potassium Monosulfate, Sodium Carbonate,Anhydrous,Sodium Percarbonate,TAED, PEG-180,Sodium benzoate,Sodium Lauryl Sulfate,VP/VA, Peppermint Oil, Indigo. Directions: 1. Drop one tablet into approx 280ml of warm water (best at 40°C), make sure the denture is completely submerged. 2. Soak denture in the solution for 5-15 minutes or overnight. For best results, use once a day. 3.Rinse the denture under running water.Dry denture thoroughly before wearing. Expiry date: in 36 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 |
|---|---|---|---|---|
| EFT | Cleanser, Denture, Over The Counter | Dental | 872.3520 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35871 | Denture cleanser | An agent intended to be used to remove soft debris from removable prosthetic dental appliances (e.g., dentures or bridges), normally by the immersion of the prosthesis/appliance in the agent overnight and/or mechanical cleaning with a toothbrush. It is intended for home-use and/or for hospitalized or institutionalized patients. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 16943566100115 | GS1 | ||||
| Primary | 06943566100118 | GS1 |