Y-Kelin
GUDID 06943566100163
Products Name: Y-Kelin Denture Adhesive Cushions for Lower Dentures Specification: 30 pieces Composition: Vicose Fiber, Alginate. Applicable People: For complete dentures. Products Features: Increase the absorbability of the removable denture and the alveolar ridge. Extra strong secure hold. Does not affect taste. Directions: Applying: 1. Overlap cushion with the denture and trim to fit; 2. Lightly soak the cushion with water and press it into denture; 3. Wear denture and bite down with rocking motion for 15 seconds.. Removing: 1. If you have trouble removing, swish some warm water; 2. Slowly remove denture using a rocking motion; 3. Remove the cushion completely and clean with denture brush and soak in cleansing tablet solution until next use. Adverse reactions: Isolated cases of hypersensitivity reactions in the mucous membranes of the mouth. Please consult a medical professional. Contraindications: Hypersensitivity to one of the ingredients. Caution: If irritation occurs, discontinue use. The products can not be resued. Keep out of reach of children. Allergy caution. Store: A dark and dry place. Expiry date: 3 years
ANHUI GREENLAND BIOTECH CO.,LTD
Denture cushion Denture cushion Denture cushion Denture cushion Denture cushion Denture cushion Denture cushion Denture cushion Denture cushion Denture cushion Denture cushion Denture cushion Denture cushion Denture cushion Denture cushion Denture cushion Denture cushion Denture cushion Denture cushion Denture cushion Denture cushion Denture cushion Denture cushion Denture cushion Denture cushion Denture cushion Denture cushion| Primary Device ID | 06943566100163 |
| NIH Device Record Key | 565e2c14-2652-4d4c-aa5b-f3334dbf06db |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Y-Kelin |
| Version Model Number | 30 pads |
| 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 | true |
| 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 |
Operating and Storage Conditions
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06943566100163 [Primary] |
| GS1 | 06943566100644 [Package] Package: PE bag [2 Units] Discontinued: 2024-12-31 In Commercial Distribution |
| GS1 | 6943566100163 [Unit of Use] |
FDA Product Code
| EHS | Cushion, 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 | 2019-04-29 |
| Device Publish Date | 2019-04-19 |
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 |
Trademark Results [Y-Kelin]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 Y-KELIN 88844974 not registered Live/Pending |
Anhui Greenland Biotech Co., Ltd 2020-03-23 |
 Y-KELIN 88844969 not registered Live/Pending |
Anhui Greenland Biotech Co., Ltd 2020-03-23 |
 Y-KELIN 88844967 not registered Live/Pending |
Anhui Greenland Biotech Co., Ltd 2020-03-23 |
 Y-KELIN 88825184 not registered Live/Pending |
Anhui Greenland Biotech Co., Ltd 2020-03-06 |
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