# K222830: Rainbow 360

- Pathway: 510(k) (Traditional)
- Applicant: Kerr Corporation
- Decided: Jan 12, 2023 after 115 days
- Product code: KLE (Agent, Tooth Bonding, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K900510 (1990). 37 ancestors in all.
No later device cites it as a predicate yet.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192961: ADH19, 3M Deutschland GmbH (2019) Summary page 4.

## Indications for use
Direct Applications • Light-cure, self-cure and dual cure composite and compomer restorations. • Composite/ceramic/metal repairs. • Tooth preparation and root surface sealer. • Cavity sealing for amalgam restorations. • Light-cured or dual-cured core build-ups. • Bonding of methacrylate-based fissure sealants. Indirect Applications • Cementation of veneers • Cementation of porcelain, composite, and metal-based restorations • Cementation of endodontic posts • Cavity sealing as a pretreatment for indirect restorations. • Prime metal, ceramic, and composite substrates/restorations.

Source page: https://510kreport.com/device/K222830
Methodology: https://510kreport.com/methodology