# K935154: Dentaurum Expansion Screws

- Pathway: 510(k) (Traditional)
- Applicant: Dentauraum, Inc.
- Decided: Feb 3, 1994 after 98 days
- Product code: DYJ (Retainer, Screw Expansion, Orthodontic)
- Device class: 1
- Regulation: 21 CFR 872.5410
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend 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)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K232887: Invisalign Palatal Expander System (2023), 1 descendant of its own
- K252931: Invisalign® Palatal Expander System (2025), 0 descendants of its own

Source page: https://510kreport.com/device/K935154
Methodology: https://510kreport.com/methodology