# K081900: Temporary Tooth Replacement

- Pathway: 510(k) (Traditional)
- Applicant: Ormco Corp.
- Decided: Oct 24, 2008 after 113 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.
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 FDA summary names its predicate without a number.
- (no number) Dentatus, Monorail Transitional Implant (MTI): named in the summary without a submission number

## Indications for use
The Transitional Tooth Replacement is intended to be used as a temporary restorative application for placement in the bone of the upper arch. The purpose is to provide support for temporary, fixed cosmetic provisional restorations. The implant is intended for patients with congenitally missing teeth, primarily the Upper Lateral Incisors.

Source page: https://510kreport.com/device/K081900
Methodology: https://510kreport.com/methodology