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Nexcomp B2

Meta Biomed Co., Ltd. · Model 9444 · UDI-DI 08806387894445

EBF Prescription

510(k) clearances

962

Adverse events (1 deaths)

Recalls

206

Facilities

Description

Nexcomp is a highly filled (75 wt.%), light-cured hybrid composite. The material is radiopaque and indicated for all types of cavity preparations. The hybrid blend has an ultra fine filler and 40 nm silica particles. Nexcomp will be marketed in incisal, body translucent, and body opaque shades which correspond with the Vita shade guide.

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.