# K221152: CuringPen Dental Curing Light

- Pathway: 510(k) (Traditional)
- Applicant: Changzhou Sifary Medical Technology Co., Ltd.
- Decided: Nov 23, 2022 after 217 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 K091020 (2009). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200809: D-LUX+, DiaDent Group International (2020) Summary page 4.

## Most influential descendants
- K253131: Curing Light (M-Cure 6) (2026), 0 descendants of its own

## Indications for use
The CuringPen Dental Curing Light is intended to polymerize resinous dental materials, restorative composite materials, and orthodontic brackets, bonding and sealing materials that are photo-polymerized in the 380-515nm waveband of visible light. This device must only be used in hospital environments, clinics or dental offices by qualified dental personnel and not used in the oxygen-rich environment.

Source page: https://510kreport.com/device/K221152
Methodology: https://510kreport.com/methodology