Y-Kelin

GUDID 16943566100115

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

ANHUI GREENLAND BIOTECH CO.,LTD

Denture cleanser

• Primary Device ID: 16943566100115
• NIH Device Record Key: 9814723d-cf11-4dab-8808-2e61c90360e9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Y-Kelin
• Version Model Number: 30 Tablets
• Company DUNS: 544396491
• Company Name: ANHUI GREENLAND BIOTECH CO.,LTD
• Device Count: 30
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06943566100118 [Primary]
GS1	16943566100115 [Unit of Use]

FDA Product Code

• EFT: Cleanser, Denture, Over The Counter

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-12-14
• Device Publish Date: 2022-12-06

On-Brand Devices [Y-Kelin]

• 06943566100637: Products Name: Y-Kelin Denture Adhesive Cushion for Upper Dentures Specification: 30 pieces Comp
• 06943566100651: Products Name: Y-Kelin Denture Adhesive Cushion Upper 30 pad + Lower 30 pads Specification: Upp
• 06943566100163: Products Name: Y-Kelin Denture Adhesive Cushions for Lower Dentures Specification: 30 pieces Co
• 16943566107398: Product Name:Plaque Indicator Specification:0.3g/piece*12/box Manufacturer:Anhui Greenland Biote
• 06943566100514: Product Name:Plaque Indicator Specification:0.3g/piece*12/box Manufacturer:Anhui Greenland Biote
• 06943566100378: Product Name:Y-kelin Denture Adhesive Powder. Composition: Sodium Alginate. Scope of applicable
• 06943566100187: Product Name: Y-kelin Adhesive Cream for Upper and Lower Dentures. Specification:40g. Main Ingre
• 16943566100115: Product Name:Y-Kelin Denture Cleansing Tablet Features: Quickly dissolve and remove stains and