# K981091: Neocolloid, Orthoprint

- Pathway: 510(k) (Traditional)
- Applicant: Zhermack S.P.A.
- Decided: May 21, 1998 after 57 days
- Product code: ELW (Material, Impression)
- Device class: 2
- Regulation: 21 CFR 872.3660
- Recalls of this device: none
- 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
- K143575: Accu-Dent XD Tray, Accu-Dent XD Syringe (2015), 0 descendants of its own

## Indications for use
Neocolloid and Orthoprint are alginate dental impression materials that are intended to be used to make dental impressions. The resulting impressions are used to make plaster models of the teeth.

Source page: https://510kreport.com/device/K981091
Methodology: https://510kreport.com/methodology