# K990699: Ortho-Glow Glitter

- Pathway: 510(k) (Traditional)
- Applicant: Harry J. Bosworth Co.
- Decided: May 17, 1999 after 75 days
- Product code: EBI (Resin, Denture, Relining, Repairing, Rebasing)
- Device class: 2
- Regulation: 21 CFR 872.3760
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
Decorative additive for acrylic resin systems to add glitter and/or metallic appearance and/or artistic shapes/designs to orthodontic retainers, and other orthodontic appliances and to dentures, splints, and mouth guards.

Source page: https://510kreport.com/device/K990699
Methodology: https://510kreport.com/methodology