# K143575: Accu-Dent XD Tray, Accu-Dent XD Syringe

- Pathway: 510(k) (Abbreviated)
- Applicant: Ivoclar Vivadent, Inc.
- Decided: Apr 3, 2015 after 107 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
Longest line of descent: 1 generation back to K981091 (1998). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043131: Torpicalgin, Zhermack S.P.A. (2004) Summary page 4.
- K981091: Neocolloid, Orthoprint, Zhermack S.P.A. (1998) Summary page 4.

## Indications for use
The Accu-Dent XD impression materials are recommended for used to create highly detailed impressions of the hard and soft tissues of the oral cavity includin the following list of indications: e Complete and partial denture impressions Opposing models for fixed and removable prosthesis Study Model Temporary crown & Bridge impressions Whitening Trays Mouth Guards Orthodontic Impressions

Source page: https://510kreport.com/device/K143575
Methodology: https://510kreport.com/methodology