Identity
- Trade Name
- Y-Kelin FDA UDI
- Generic Name
- Denture cleanser FDA UDI
- Device Name
- Product Name:Y-Kelin Denture Cleansing Tablet Features: Quickly dissolve and remove stains and plaques with the power of reactive oxygen. Keep dentures extra fresh and clean with minty flavor. Can be used for full dentures, partial dentures, removable retainers. Ingredients: Sodium Bicarbonate, Citric Acid, Potassium Monosulfate, Sodium Carbonate,Anhydrous,Sodium Percarbonate,TAED, PEG-180,Sodium benzoate,Sodium Lauryl Sulfate,VP/VA, Peppermint Oil, Indigo. Directions: 1. Drop one tablet into approx 280ml of warm water (best at 40°C), make sure the denture is completely submerged. 2. Soak denture in the solution for 5-15 minutes or overnight. For best results, use once a day. 3.Rinse the denture under running water.Dry denture thoroughly before wearing. Expiry date: in 36 months. Manufacturer: Anhui Greenland Biotech Co.,Ltd. Add: Mohekou Industrial Zone, Bengbu, Anhui, China. Tel:0552-5875300 FDA UDI
- Model / Reference
- 30 Tablets FDA UDI
- Description
- Product Name:Y-Kelin Denture Cleansing Tablet Features: Quickly dissolve and remove stains and plaques with the power of reactive oxygen. Keep dentures extra fresh and clean with minty flavor. Can be used for full dentures, partial dentures, removable retainers. Ingredients: Sodium Bicarbonate, Citric Acid, Potassium Monosulfate, Sodium Carbonate,Anhydrous,Sodium Percarbonate,TAED, PEG-180,Sodium benzoate,Sodium Lauryl Sulfate,VP/VA, Peppermint Oil, Indigo. Directions: 1. Drop one tablet into approx 280ml of warm water (best at 40°C), make sure the denture is completely submerged. 2. Soak denture in the solution for 5-15 minutes or overnight. For best results, use once a day. 3.Rinse the denture under running water.Dry denture thoroughly before wearing. Expiry date: in 36 months. Manufacturer: Anhui Greenland Biotech Co.,Ltd. Add: Mohekou Industrial Zone, Bengbu, Anhui, China. Tel:0552-5875300 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06943566100118 FDA UDI
- FDA Product Code
- EFT FDA UDI
- GMDN Term
- Denture cleanser FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.3520 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Denture cleanser
Y-Kelin by Anhui Greenland Biotech Co., Ltd — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Anhui Greenland Biotech Co., Ltd
Sources (2)
- FDA UDI 9814723d-cf11-4dab-8808-2e61c90360e9 33 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 2, 2026