Y-Kelin
Basic Information
- Brand Name
- Y-Kelin
- Primary DI
- 06943566100095
- Version / Model
- 30 pads
- Company Name
- ANHUI GREENLAND BIOTECH CO.,LTD
- Labeler DUNS
- 544396491
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 30
- Record Status
- Published
- Publish Date
- 2019-04-15
- Public Version
- 3
- Public Version Date
- 2022-11-24
- Public Version Status
- Update
- Public Device Record Key
- c33cb832-63f9-4879-995c-3349a1b28c1f
Device Description
Products Name: Y-Kelin Denture Adhesive Cushion for Upper Dentures Specification: 30 pieces 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
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EHS | Cushion, Denture, Over The Counter | Dental | 872.3540 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 11170 | Denture cushion | A prefabricated device intended to be used to improve the fit of a loose or ill-fitting (uncomfortable) denture. It is typically self-applied by a patient in the home and serves as a temporary measure until replacement dentures are made. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 06943566100637 | GS1 | PE bag | 2 | In Commercial Distribution | |
| Primary | 06943566100095 | GS1 | ||||
| Unit of Use | 6943566100095 | GS1 |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 0 – 40 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 0 – 40 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius