# K190571: StoneBite and StoneBite scan

- Pathway: 510(k) (Abbreviated)
- Applicant: Dreve Dentamid GmbH
- Decided: Nov 7, 2019 after 246 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: 2 generations back to K954281 (1996). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081120: Futar (Futar, Futar D, Futar D Fast, Futar D Slow, Futar Scan Bite Registration Materials, Kettenbach GmbH & Co. KG (2008) Summary page 4.

## Most influential descendants
- K250969: Jet Bite; Jet Blue Bite Fast; Jet Blue Bite Superfast (2025), 0 descendants of its own

## Indications for use
StoneBite© and StoneBite© scan are addition-curing silicones for bite registrations. StoneBite© is indicated for: ▪ bite registrations ▪ key for intraoral registration StoneBite© scan is indicated for: ▪ bite registrations ▪ key for intraoral registration ▪ optical collection of data in CAD/CAM/CIM systems

Source page: https://510kreport.com/device/K190571
Methodology: https://510kreport.com/methodology