# K131906: Scanwave Pen (with Light Gray Cord), Scanwave Pen (with Medium Gray Cord), Scanwave Pen (with Dark Gray Cord), Scanwave

- Pathway: 510(k) (Abbreviated)
- Applicant: Satelec - Acteon Group
- Decided: Apr 11, 2014 after 289 days
- Product code: EBZ (Activator, Ultraviolet, For Polymerization)
- Device class: 2
- Regulation: 21 CFR 872.6070
- 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 K961735 (1996). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072181: Mini Led Autofocus, Satelec (2007) Summary page 2.
- K091020: Bluephase 20I, Ivoclar Vivadent, Inc. (2009) Summary page 5.

## Indications for use
SCANWAVE PEN is a source of illumination for the polymerization of light-curing dental materials curing in the wavelength range of 390 nm - 505 nm.

Source page: https://510kreport.com/device/K131906
Methodology: https://510kreport.com/methodology