# K141439: Orthodontic Acrylic (Not Finalized)

- Pathway: 510(k) (Traditional)
- Applicant: Bisco, Inc.
- Decided: Sep 12, 2014 after 102 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
Longest line of descent: 1 generation back to K941925 (1994). 1 ancestor in all.
1 later device descends from it; 1 cites 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)
- K941925: Ortho-Jet Acrylic Resin - Sparkle, Lang Dental Mfg. Co., Inc. (1994) Summary page 4.
- (no number) Ortho-Jet: named in the summary without a submission number

## Most influential descendants
- K163482: Orthodontic Acrylic 2 (2017), 0 descendants of its own

## Indications for use
Orthodontic Acrylic is intended for the fabrication of methacrylate-based orthodontic appliances (such as retainers, bite guards, and bite plates, etc.)

Source page: https://510kreport.com/device/K141439
Methodology: https://510kreport.com/methodology