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Vittra APS Unique

Dentscare Ltda · Model Caps · UDI-DI 07899633829316

EBF Prescription

510(k) clearances

961

Adverse events (1 deaths)

Recalls

207

Facilities

Description

Light-curing composite for all dental shades for use in anterior and posterior restorations, recommended for all classes of cavities. The optical properties of Vittra APS Unique come from a fine balance between refractive indices of the dental structure versus that of the resin, which results in the propagation of the base color (dental remnant) through the resin structure. This effect causes the resin to "assume" (or transmit) the tooth color. It has a fundamental role, the loads, the well-balanced opacity of the product and the aesthetic of the APS system.

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.