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EsCom250

Spident Co., Ltd. · Model EsCom250 Capsule C2 20ea · UDI-DI 08809262953404

EBF

510(k) clearances

961

Adverse events (1 deaths)

Recalls

207

Facilities

Description

EsCom250 is the polymer-based dental restorative material. It can be light-cured intra orally for anterior and posterior restoration including occlusal surface. Various shades of A1, A2, A3, A3.5, A4, B1, B2, C2, D2, G1, AO2, AO3 and TW for esthetic restoration are provided. All shades of EsCom250 are radio-opaque.

Recalls

Date	Firm	Reason
2026-07-09	Henry Schein Inc.	Specific lots were distributed in the US with incorrect packaging and Instructions for Use (IFU) from the U.S. FDA-cleared device.
2026-07-09	Henry Schein Inc.	Specific lots were distributed in the US with incorrect packaging and Instructions for Use (IFU) from the U.S. FDA-cleared device.
2024-08-02	Ultradent Products, Inc.	Due to a manufacturing issue, red particulates present in the expressed composite.
2024-08-02	Ultradent Products, Inc.	Due to a manufacturing issue, red particulates present in the expressed composite.
2024-08-02	Ultradent Products, Inc.	Due to a manufacturing issue, red particulates present in the expressed composite.
2020-08-31	Ultradent Products, Inc.	Due to a potential manufacturing issue (cross contamination), composite is non-homogeneous.
2019-07-09	Voco GmbH	The metal cannula are potentially too loose and may become loose when applying the filing material.
2019-01-31	RHONDIUM LIMITED	The product was mislabeled with an incorrect expiration date.
2017-08-03	Ivoclar Vivadent, Inc.	Complaints were filed claiming the material consistency was too soft and too sticky in comparison to its usual consistency, causing unexpected handling for the user during packing
2017-08-03	Ivoclar Vivadent, Inc.	Complaints were filed claiming the material consistency was too soft and too sticky in comparison to its usual consistency, causing unexpected handling for the user during packing

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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.