# K083886: Simpler Mini Implant, Models SM 5002, SM 5003, SM 5004

- Pathway: 510(k) (Traditional)
- Applicant: Simpler One Stop
- Decided: Mar 23, 2009 after 84 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: 3 generations back to K021045 (2002). 7 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073645: Simpler Mini Dental Implant: SM 3002 2.5 X 10MM, SM 3003 2.5 X 13MM, SM 3004 2.5 X 15MM, 659543 BC, Ltd. (2008) Summary page 1.
- K974856: 3.25MM Simpler Threaded Dental Implant, Vancouver Implant Resources, Inc. (1998) 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.

## Most influential descendants
- K121281: Simpli Simpler Implant System (2013), 0 descendants of its own
- K092674: Simpler Toadstool Mini Implant (2009), 0 descendants of its own

## Indications for use
The Simpler Mini Implants (ID SM3002-4) and the Simpler HA Mini Implants (ID SM5002-4) are intended to provide long term intra-bony applications. They are designed for immediate loading when there is good primary stability and an appropriate occlusal load. They may also be used for temporary support for partial and fully edentulous restoration in the mandible and maxilla. They may be used for full or partial edentulism and are used as an option to provide a minimally invasive surgical intervention.

Source page: https://510kreport.com/device/K083886
Methodology: https://510kreport.com/methodology