# K121281: Simpli Simpler Implant System

- Pathway: 510(k) (Abbreviated)
- Applicant: Simpler Implant Solutions
- Decided: Apr 5, 2013 after 340 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: 11 generations back to K960026 (1996). 87 ancestors in all.
No later device cites it as a predicate yet.
0 of 88 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.
- K081653: Mdi Mii One-Piece Implant, 2.9MM, Imtec Corp. (2008) Summary page 1.
- K032351: The Maestro System 3.0MM Diameter Implant, BioHorizons Implant Systems, Inc. (2003) Summary page 1.
- K080115: I-Mini Dental Implant, Oco Biomedical (2008) Summary page 1.

## Indications for use
The SIMPLI Simpler Implant System is indicated for use in surgical and restorative applications for placement of implants in the mandible and maxilla to provide support for prosthetic devices such as artificial teeth to provide chewing function to a patient with missing teeth. It is also indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

Source page: https://510kreport.com/device/K121281
Methodology: https://510kreport.com/methodology