# K051751: Equa-Pull Safety Release Module

- Pathway: 510(k) (Traditional)
- Applicant: Ortho Technology
- Decided: Jul 22, 2005 after 23 days
- Product code: DZB (Headgear, Extraoral, Orthodontic)
- Device class: 2
- Regulation: 21 CFR 872.5500
- 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
Equa Pull Constant Force Headgear is a safety release module used during the wear of Orthodontic Head Gear products, connected to Orthodontic Face Bows. The module is designed to provide pull force for treatment at light (12 ounce) or heavy (24 ounce) levels, and a release point force (60-90 ounces) for patient safety. The devices are for Orthodontic Use Only, on the order of an Orthodontist.

Source page: https://510kreport.com/device/K051751
Methodology: https://510kreport.com/methodology