# K040769: Structur 2 SC

- Pathway: 510(k) (Special)
- Applicant: Voco GmbH
- Decided: Apr 7, 2004 after 13 days
- Product code: EBG (Crown And Bridge, Temporary, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3770
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K214071: Hexa-Temp (2022), 0 descendants of its own

## Recalls of this device
- Jul 9, 2026 · Class II · Z-3015-2026: Specific lots were distributed in the US with incorrect packaging and Instructions for Use (IFU) from the U.S. FDA-cleared device.

## Indications for use
cold-polymerizing paste-paste system for the preparation of temporary crowns, bridges, inlays and onlays

Source page: https://510kreport.com/device/K040769
Methodology: https://510kreport.com/methodology