# K052553: Nitom Locking Facebow

- Pathway: 510(k) (Traditional)
- Applicant: Russell Samuels Orthodontic Design
- Decided: Dec 22, 2005 after 97 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. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K080245: Nitom Locking Icebow. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
The Nitorm Locking facebow is a type of orthodontic facebow used in Orthodontic treatment with a neckstrap or headcap to hold or move the upper back teeth backwards. It has two catches or locks on the inner bow to prevent it accidentally coming out at night.

Source page: https://510kreport.com/device/K052553
Methodology: https://510kreport.com/methodology