Y-Kelin
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…
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
Who Else Makes It
Concentrated in Shanghai (1), Anhui (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| ALL About Inspired Company Limited | Shanghai | Shanghai | Manufacturer | 12 |
| Anhui Greenland Biotech Co., Ltd. | Bengbu | Anhui | Manufacturer | 6 |
Record
| Listed by | Anhui Greenland Biotech Co., Ltd., China |
|---|---|
| FDA product code | EHS |
| Device type | Cushion, Denture, Over The Counter |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3540 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2019-04-19 |
| Record revised | 2024-12-31 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Handling environment temperature 15 to 30 °C; Handling environment humidity 0 to 40 % RH; Storage environment temperature 15 to 30 °C; Storage environment humidity 0 to 40 % RH |
| Packaging | Pe bag of 2 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| upper 30 pads + lower 30 pads | 60 | In distribution | |
| 30 pads | 30 | In distribution | |
| 30 pads | 30 | In distribution |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.