# K062735: Tutu 7, Model IV-T22

- Pathway: 510(k) (Traditional)
- Applicant: Invisible Technology Co., Ltd.
- Decided: Oct 27, 2006 after 44 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: 4 generations back to K951425 (1995). 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)
- K041372: Smartlite PS Pen-Style Led Curing Light, Dentsply International (2004) Summary page 1.
- K011154: Elipar Freelight, Espe Dental AG (2001) Summary page 1.

## Indications for use
The TUTU TM LED intraoral curing light is designed to polymerize visible light cure (VLC) dental materials including dental pit and fissure sealants, bonding adhesives, cements, restorative or luting materials

Source page: https://510kreport.com/device/K062735
Methodology: https://510kreport.com/methodology