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SECURE Denture Adhesive

FITTYDENT INTERNATIONAL GmbH · Model KL40 F0140DUS · UDI-DI 00364031300103

KOO

510(k) clearances

773

Adverse events (12 deaths)

Recalls

Facilities

Description

An adhesive compound composed of carboxymethylcellulose sodium (usually 40 to 100%) used to stabilize a removable prosthesis in the mouth, particularly a denture, by adhering the prosthesis to the oral mucosa. The compound is typically applied to the base of a denture before it is inserted in the mouth. 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.