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edelweiss VENEER SET 14-24 S up

edelweiss dentistry products gmbh · Model 13000 · UDI-DI 09120046322124

EBF

510(k) clearances

961

Adverse events (1 deaths)

Recalls

207

Facilities

Description

SET of total 8 pcs VENEERS (1x edelweiss VENEER 14 S, 1x edelweiss VENEER 13 S, 1x edelweiss VENEER 12 S, edelweiss VENEER 11 S, edelweiss VENEER 21 S, edelweiss VENEER 22 S, edelweiss VENEER 23 S and edelweiss VENEER 24 S)

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.