# K112397: Ortho-Jet Crystal

- Pathway: 510(k) (Traditional)
- Applicant: Lang Dental Mfg. Co., Inc.
- Decided: Nov 4, 2011 after 77 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
Lang Dental Ortho-Jet Crystal, Clear Acrylic Resin is intended for the fabrication of methacrylate-based orthodontic appliances and is intended for use when aesthetically clear acrylic appliances, such as orthodontic retainers, are desired.

Source page: https://510kreport.com/device/K112397
Methodology: https://510kreport.com/methodology