# K241238: LOOP™ LED Curing Light System (CLK01)

- Pathway: 510(k) (Traditional)
- Applicant: Garrison Dental Solutions, LLC
- Decided: Aug 1, 2024 after 90 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 K003383 (2001). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200775: LOOP LED Curing Light System, Garrison Dental Solutions, LLC (2020) Summary page 6.

## Indications for use
Indications for Use: LOOP™ is a source of illumination for curing photo-activated dental restorative materials and adhesives.

Source page: https://510kreport.com/device/K241238
Methodology: https://510kreport.com/methodology