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Y-Kelin

ANHUI GREENLAND BIOTECH CO.,LTD · Model 30 Tablets · UDI-DI 06943566100118

EFT

510(k) clearances

776

Adverse events (32 deaths)

Recalls

130

Facilities

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

Recalls

Date	Firm	Reason
2023-10-04	Family Dollar Stores, Llc.	Products were stored outside of labeled temperature requirements.
2022-06-23	Family Dollar Stores, Llc.	Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.
2022-06-23	Family Dollar Stores, Llc.	Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.