# K980792: CU-100A Light Cure Unit

- Pathway: 510(k) (Traditional)
- Applicant: Rolence Enterprise Co., Ltd.
- Decided: May 15, 1998 after 74 days
- Product code: EBF (Material, Tooth Shade, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3690
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K993223: Rapicure 200 (Curing and Whitening Light) (1999), 0 descendants of its own
- K992357: Easy-Cure (Curing and Whitening Light) (1999), 0 descendants of its own

## Indications for use
TO PRODUCE LIGHT RANGE BETWEEN 400 & 500 NM TO POLYMERIZE LIGHT CURE DENTAL RESTORATIVE MATERIAL SUCH AS LIGHT CURE COMPOSITES, PIT AND FISSURE SEALANTS, BONDING AGENTS, ADHESION PRIMERS ETC. WHICH ARE APPLIED IN THE RESTORATION OF FUCTION AND APPEARANCE OF THE TEETH OF PATIENT.

Source page: https://510kreport.com/device/K980792
Methodology: https://510kreport.com/methodology