# K042414: Visioplast Acrylic Resin

- Pathway: 510(k) (Traditional)
- Applicant: Tecres
- Decided: Dec 29, 2004 after 113 days
- Product code: GXP (Methyl Methacrylate For Cranioplasty)
- Device class: 2
- Regulation: 21 CFR 882.5300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K873689 (1987). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K873689: Cranioplastic, Acrylic Cranioplasty Material, Dentsply Intl. (1987) Summary page 1.

## Most influential descendants
- K063438: Vspspn (2007), 0 descendants of its own

## Indications for use
Visioplast Acrylic Resin is a resinous material for repairing cranial defects.

Source page: https://510kreport.com/device/K042414
Methodology: https://510kreport.com/methodology