# K092542: M

- Pathway: 510(k) (Traditional)
- Applicant: Mediscitec, Inc.
- Decided: Apr 23, 2010 after 247 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The M root-form endosseous dental implant fixture is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore the patient's chewing function. The M endosseous dental implant abutment is intended to be used with the root-form endosseous dental implant to aid in prosthetic rehabilitation. The M root-form endosseous dental implant is not intended for immediate loading.

Source page: https://510kreport.com/device/K092542
Methodology: https://510kreport.com/methodology