Y-Kelin

GUDID 06943566100514

Product Name:Plaque Indicator Specification:0.3g/piece*12/box Manufacturer:Anhui Greenland Biotech Co., Ltd Address:No.5, Kaiyuan Rd,Mchekou Industrial Zone, Huaishang District,Bengbu, Anhui,China Tel:0552-5875300 Product performance:Used to show plaquue, assist oral examination and treatment Main ingredients:Erythrosine, Blue No.1 AluminumLake, Glucose, Silica, PEG-180, Magnesium Stearate, Spices Scope of application:Suitable for peoplewho are expected to show dental plaque Contraindications: 1.People who are allergic to ingredients are prohibited to use. 2.Do not swallow directly. 3.Use with caution for pregnant women and infants. Instructions: 1.Take a piece of plaque indicator into your mouth and chew it, lick it with the tip of your tongue to the inside and outside of the entire tooth surface, and hold it in your mouth for about 1 minute. 2.Spit out the residue in your mouth and rinse your mouth with water. 3. Check the oral cavity with a mirror, the stained part of the tooth surface is the part where the plaque is attached. Store: This product is stored in a ventilated and dry place at room temperature. Transportation conditions/methods:Transportation conditions and methods must meet the requirements of the instructions and signs. Period of use: Three years.

ANHUI GREENLAND BIOTECH CO.,LTD

Dental caries detecting stain Dental caries detecting stain Dental caries detecting stain Dental caries detecting stain Dental caries detecting stain Dental caries detecting stain Dental caries detecting stain Dental caries detecting stain Dental caries detecting stain Dental caries detecting stain Dental caries detecting stain Dental caries detecting stain

• Primary Device ID: 06943566100514
• NIH Device Record Key: 8bc70c1e-7a9a-44f3-8e25-0aa939dfb2a8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Y-Kelin
• Version Model Number: 12 Tablets
• Company DUNS: 544396491
• Company Name: ANHUI GREENLAND BIOTECH CO.,LTD
• Device Count: 12
• 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	06943566100514 [Primary]
GS1	16943566100511 [Unit of Use]

FDA Product Code

• KJR: Erythrosin B

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