# K250969: Jet Bite; Jet Blue Bite Fast; Jet Blue Bite Superfast

- Pathway: 510(k) (Abbreviated)
- Applicant: Dent4you AG
- Decided: Jun 27, 2025 after 88 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: 3 generations back to K954281 (1996). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190571: StoneBite and StoneBite scan, Dreve Dentamid GmbH (2019) Summary page 5.

## Indications for use
JET BITE & JET BLUE BITE are intended for the registration of occlusion in cases where relationship between the relative positions of maxilla and mandible is required.

Source page: https://510kreport.com/device/K250969
Methodology: https://510kreport.com/methodology