# K251724: Remi Impression Material

- Pathway: 510(k) (Traditional)
- Applicant: Grindguard, Inc.
- Decided: Feb 25, 2026 after 266 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.
1 later device descends from it; 1 cites it directly.
0 of 10 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 6.

## Most influential descendants
- K261888: ClearClub Impression Material (2026), 0 descendants of its own

## Indications for use
The Remi Impression Material is intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums to fabricate patient matched nightguards/mouthguards.

Source page: https://510kreport.com/device/K251724
Methodology: https://510kreport.com/methodology