# K820944: Dental Arch Bar

- Pathway: 510(k) (Traditional)
- Applicant: Unisplint Corp.
- Decided: May 5, 1982 after 29 days
- Product code: DYX (Lock, Wire, And Ligature, Intraoral)
- Device class: 2
- Regulation: 21 CFR 872.4600
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
31 later devices descend from it; 4 cite it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K963030: Leibinger Imf Screw (1997), 25 descendants of its own
- K991004: Synthes Quick Lock Imf System (1999), 15 descendants of its own
- K031207: Safety Release Arch Bar Kit (2003), 14 descendants of its own
- K061271: Erch Arch Bar, Model 38-690-00 (2006), 13 descendants of its own
- K050535: Stryker MMF Screw (2005), 11 descendants of its own

Source page: https://510kreport.com/device/K820944
Methodology: https://510kreport.com/methodology