# K122052: Minifix Ball Minifix One

- Pathway: 510(k) (Traditional)
- Applicant: Bonafix Surgical and Dental Implants, LLC
- Decided: Nov 28, 2012 after 139 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). 83 ancestors in all.
No later device cites it as a predicate yet.
0 of 84 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081653: Mdi Mii One-Piece Implant, 2.9MM, Imtec Corp. (2008) Summary page 1.
- K100932: Inclusive Mini Implant, Prismatik Dentalcraft, Inc. (2010) Summary page 1.
- K070601: Mini Drive-Lock Dental Implant System, Intra-Lock International (2007) Summary page 1.

## Indications for use
The proposed MiniFix implant system consists of MiniFix One and MiniFix Ball implants. The MiniFix One implants are indicated to provide support for single unit dental prostheses in the mandibular central and lateral incisor and maxillary lateral incisor regions of partially edentulous jaws. The MiniFix One implant must be splinted if two or more are used adjacent to each other. The MiniFix One implant may be immediately restored with a temporary prosthesis that is not in functional occlusion. The MiniFix Ball implants are intended to be placed throughout the maxillary and mandibular arches to provide support for multi-unit restorations on long-term or short term fixation of upper and lower dentures. Immediate loading should only be done in the presence of primary stability and appropriate occlusal loading.

Source page: https://510kreport.com/device/K122052
Methodology: https://510kreport.com/methodology