# K040143: Monorail

- Pathway: 510(k) (Traditional)
- Applicant: Nats Corp.
- Decided: Sep 13, 2004 after 235 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
145 later devices descend from it; 1 cites it directly.
0 of 146 devices 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.

## Most influential descendants
- K070601: Mini Drive-Lock Dental Implant System (2007), 144 descendants of its own
- K073343: Ace Surgical Secure-Mini Implant System, Model 09-270X-XX (2008), 135 descendants of its own
- K092594: Ace Surgical Secure- Mini Locator Implant System, Model 09-2702-OX, 09-2703-OX, 09-2705-OX (2009), 134 descendants of its own
- K123022: Neodent Implant System (2013), 127 descendants of its own
- K133510: Neodent Implant System (2014), 123 descendants of its own

## Indications for use
The Monorail T" Endosseous Implant is intended for use as a self-tapping titanium screw for transitional or intra-bony long-term applications or any length of time as decided by the Health Care provider.

Source page: https://510kreport.com/device/K040143
Methodology: https://510kreport.com/methodology