Identity
- Trade Name
- Y-Kelin FDA UDI
- Generic Name
- Denture cushion FDA UDI
- Device Name
- Products Name: Y-Kelin Denture Adhesive Cushion Upper 30 pad + Lower 30 pads Specification: Upper 30 pieces/box + Lower 30 pieces/box Composition: Sodium alginate, Polyester fiber, Viscose fiber. 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: 1. Clean and moisten the dentures. 2.If the cushion is too large, cut the cushion to appropriate with scissor, keep in mind that leaving the denture margin of 2mm, Do not cover. 3. Moisten the adhesive cushion in warm water, place and press it on the denture. Press the cushion with two thumbs from the denture center to the sides, until the cushion is completely flat docile. 4 . Place dentures into mouth. Hold firmly until secure. 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: in 36 months FDA UDI
- Model / Reference
- upper 30 pads + lower 30 pads FDA UDI
- Description
- Products Name: Y-Kelin Denture Adhesive Cushion Upper 30 pad + Lower 30 pads Specification: Upper 30 pieces/box + Lower 30 pieces/box Composition: Sodium alginate, Polyester fiber, Viscose fiber. 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: 1. Clean and moisten the dentures. 2.If the cushion is too large, cut the cushion to appropriate with scissor, keep in mind that leaving the denture margin of 2mm, Do not cover. 3. Moisten the adhesive cushion in warm water, place and press it on the denture. Press the cushion with two thumbs from the denture center to the sides, until the cushion is completely flat docile. 4 . Place dentures into mouth. Hold firmly until secure. 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: in 36 months FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06943566100651 FDA UDI
- FDA Product Code
- EHS FDA UDI
- GMDN Term
- Denture cushion FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3540 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Denture cushion
Y-Kelin by Anhui Greenland Biotech Co., Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Denture cushion.
- Y-Kelin — ANHUI GREENLAND BIOTECH CO., LTD · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Anhui Greenland Biotech Co., Ltd
Sources (1)
- FDA UDI c4a52ed5-39b9-4519-96ed-408e4ce5b831 34 fields · synced Jun 8, 2026