# K191865: SmartLite Pro Modular LED Curing Light

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Sirona
- Decided: Nov 20, 2019 after 131 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: 1 generation back to K061341 (2006). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061341: Palmlight 10, Model 001-00030, CAO Group, Inc. (2006) Summary page 5.
- K062961: Microlux Transilluminator, Addent, Inc. (2007) Summary page 5.

## Indications for use
For light activated polymerization of dental materials such as composites, luting cements, and sealants using visible light. For intraoral illumination used upon initial examination of the dental patient and dental transillumination to help locate crown fractures, posterior and anterior caries, and for use as an auxiliary light source for endodontic procedures.

Source page: https://510kreport.com/device/K191865
Methodology: https://510kreport.com/methodology