# K010926: R-SI-Line Metal-Bite

- Pathway: 510(k) (Traditional)
- Applicant: R-Dental Dentalerzeugnisse GmbH
- Decided: Apr 12, 2001 after 16 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
No predicates in its family tree.
4 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K081120: Futar (Futar, Futar D, Futar D Fast, Futar D Slow, Futar Scan Bite Registration Materials (2008), 3 descendants of its own
- 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

Source page: https://510kreport.com/device/K010926
Methodology: https://510kreport.com/methodology