# K053427: Fresh, Dental Impression Material

- Pathway: 510(k) (Traditional)
- Applicant: Exacta Dental Products, Inc.
- Decided: Jan 13, 2006 after 36 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: 4 generations back to K943574 (1994). 5 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052090: Splash! Impression Material Device, Discus Dental, Inc. (2005) Summary page 1.

## Most influential descendants
- K171562: Dynax clear, Dynax putty, Dynax heavy body, Dynax light, Dynax mono (2018), 4 descendants of its own
- K213244: Accusil Dental Impression Materials (Accusil Light Body Regular and Fast Set, Accusil Heavy Body Regular and Fast Set, Accusil Monophase Regular and Fast Set, Accusil Putty Regular and Fast Set, Accusil Bite Registration) (2022), 3 descendants of its own
- K251724: Remi Impression Material (2026), 1 descendant of its own
- K261888: ClearClub Impression Material (2026), 0 descendants of its own
- K251926: enCore Impression Material (2026), 0 descendants of its own

## Indications for use
Fresh, Dental Impression Material is intended for use with all crowns, bridges, occiusal and dental implant impression techniques to reproduce the structure of a patient's teeth and gums.

Source page: https://510kreport.com/device/K053427
Methodology: https://510kreport.com/methodology