# K092674: Simpler Toadstool Mini Implant

- Pathway: 510(k) (Traditional)
- Applicant: Pan Global Implant
- Decided: Dec 28, 2009 after 118 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
Longest line of descent: 4 generations back to K935544 (1995). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083886: Simpler Mini Implant, Models SM 5002, SM 5003, SM 5004, Simpler One Stop (2009) Summary page 1.
- K031106: Imtec Sendax Mdi and Mdi Plus Endosseous Implant, Models OB-XX, SH-XX, Mob-22, MSH-XX, Imtec Corp. (2003) Summary page 1.
- K050586: Leone Implant System, Leone S.P.A. (2006) Summary page 1.

## Cited in the summary but kept off the family tree
- K070601: Mini Drive-Lock Dental Implant System, Intra-Lock International (2007). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
The Simpler Toadstool Mini Implants and the Simpler HA Toadstool Mini Implants are intended to provide long term intra-bony applications for Soft Tissue Supported Over Dentures only. They are designed for immediate loading when there isgood primary stability and an minimal occlusal load. These implants may also be used for temporary soft tissue overdlenture support for partial and fully edlentulous restoration in the mandible and maxilla. They may be used as a minimally invasive surgical technique option for full or partial edentulism as an alternative to more invasive surgery involving conventional implants.

Source page: https://510kreport.com/device/K092674
Methodology: https://510kreport.com/methodology