# K041303: Led Turbo-Pen

- Pathway: 510(k) (Traditional)
- Applicant: Apoza Enterprise Co., Ltd.
- Decided: Jun 18, 2004 after 32 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: 2 generations back to K023545 (2002). 2 ancestors in all.
2 later devices descend from it; 2 cite 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)
- K040618: Led Turbo, Apoza Enterprise Co., Ltd. (2004) Summary page 1.

## Most influential descendants
- K071722: Deep Blue (2007), 0 descendants of its own
- K070373: Apoza Led Curing Light, Model E-Morlit, D-2000, Top 3W, Top 5W (2007), 0 descendants of its own

## Indications for use
The LED Turbo-Pen is a dental curing light that is designed for use in the optical polymerization of dental resins.

Source page: https://510kreport.com/device/K041303
Methodology: https://510kreport.com/methodology