# K160097: Image Fast Set, Image Regular Set

- Pathway: 510(k) (Traditional)
- Applicant: Sybron Dental Specialties
- Decided: Aug 5, 2016 after 199 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: 2 generations back to K121824 (2012). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160441: Identic and KromaFaze Alginate Dental Impression Materials, Kerr Corporation (2016). Cleared while this submission was under review Summary page 4.

## Most influential descendants
- K253501: Hydro Print Premium Fast Set - 454g (1lb) (052037); Hydro Print Premium Regular Set - 454g (1lb) (052327); Chroma Print Premium Fast Set - 454g (1lb) (052457); Chroma Print Premium Regular Set - 454g (1lb) (051460); Perfil Pro - 454g (1lb) (056213); Perfil Pro+ - 454g (1lb) (056121); Perfil Pro Chroma - 454g (1lb) (056122); Hydro Print Premium Fast Set - Multi Pack (056205); Hydro Print Premium Regular Set  - Multi Pack  (056208); Hydro Print Premium Fast Set - 9,07Kg (20lb) (056204); (2025), 0 descendants of its own

## Indications for use
Image Alginate Dental Impression materials are irreversible hydrocolloids for dental impressions used by the dentist to take the anatomical data of the patient's mouth and subsequently realize a plaster mold useful to diagnose problems, define the required interventions and/or check their effectiveness. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.

Source page: https://510kreport.com/device/K160097
Methodology: https://510kreport.com/methodology