# K261888: ClearClub Impression Material

- Pathway: 510(k) (Traditional)
- Applicant: ClearClub
- Decided: Sep 16, 2026 after 103 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: 8 generations back to K943574 (1994). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K251724: Remi Impression Material, Grindguard, Inc. (2026) Summary page 5.

## Indications for use
The ClearCub 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/K261888
Methodology: https://510kreport.com/methodology