# K251926: enCore Impression Material

- Pathway: 510(k) (Traditional)
- Applicant: Encore Guards
- Decided: Mar 17, 2026 after 267 days
- Product code: SHI (Impression Material For Fabrication Of Patient-Matched Mouthguards, Over-The-Counter)
- 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: 7 generations back to K943574 (1994). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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), Prevest Denpro Limited (2022) Summary page 5.

## Indications for use
The EnCore Impression Material is intended for dental impression techniques to reproduce the structure of a patient's dentition to fabricate patient matched night guards and mouthguards.

Source page: https://510kreport.com/device/K251926
Methodology: https://510kreport.com/methodology