# K081120: Futar (Futar, Futar D, Futar D Fast, Futar D Slow, Futar Scan Bite Registration Materials

- Pathway: 510(k) (Traditional)
- Applicant: Kettenbach GmbH & Co. KG
- Decided: May 1, 2008 after 10 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: 1 generation back to K954281 (1996). 3 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954281: Panasil Impression Material, Roydent Dental Products, Inc. (1996) Summary page 1.
- K010926: R-SI-Line Metal-Bite, R-Dental Dentalerzeugnisse GmbH (2001) Summary page 1.
- K030776: Mega Bite Registration - Dental Bite Registration Material, Discus Dental, Inc. (2003) Summary page 1.

## Most influential descendants
- K190571: StoneBite and StoneBite scan (2019), 1 descendant of its own
- K250969: Jet Bite; Jet Blue Bite Fast; Jet Blue Bite Superfast (2025), 0 descendants of its own
- K113279: Identium Heavy, Identium Medium, Identium Scan Heavy, Identium Scan Medium, Identium Scan Light (2011), 0 descendants of its own

## Indications for use
All Futar bite registration materials (Futar, FutarD, FutarD Fast, FutarD Slow, FutarScan) can be used for making accurate occlusal registrations. Futar D materials (FutarD, FutarD Fast, FutarD Slow) can be used for applications, which require a hard bite registration silicone. FutarD Fast can be used for "small applications" because of its shorter working time. FutarD Slow can be used for time-consuming bite registrations because of its longer working time. FutarScan can also be used for an optical registration of occlusal data for CAD/CAM/CIM systems without using powder.

Source page: https://510kreport.com/device/K081120
Methodology: https://510kreport.com/methodology