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SECURE Cleansing Tablets

FITTYDENT INTERNATIONAL GmbH · Model F0232DUS · UDI-DI 00364031300165

EFT

510(k) clearances

776

Adverse events (32 deaths)

Recalls

128

Facilities

Description

An agent intended to be used to remove soft debris from removable prosthetic dental appliances (e.g., dentures or bridges), normally by the immersion of the prosthesis/appliance in the agent overnight and/or mechanical cleaning with a toothbrush. It is intended for home-use and/or for hospitalized or institutionalized patients. After application, this device cannot be reused.

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.