# K121707: Lew Mdi O-Ball Collared Implant,

- Pathway: 510(k) (Traditional)
- Applicant: Park Dental Research Corp.
- Decided: Sep 24, 2012 after 105 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). 86 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 88 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031106: Imtec Sendax Mdi and Mdi Plus Endosseous Implant, Models OB-XX, SH-XX, Mob-22, MSH-XX, Imtec Corp. (2003) Summary page 2.
- K081653: Mdi Mii One-Piece Implant, 2.9MM, Imtec Corp. (2008) Summary page 2.
- K070601: Mini Drive-Lock Dental Implant System, Intra-Lock International (2007) Summary page 1.
- K050970: Milo Dental Implant System, Intra-Lock International (2005) Summary page 1.
- K100932: Inclusive Mini Implant, Prismatik Dentalcraft, Inc. (2010) Summary page 2.

## Most influential descendants
- K132178: Mostdi Dental Implant System (2014), 0 descendants of its own

## Indications for use
The Park Dental Research Corporation's LEW 0-ball implant system is a self-tapping titanium threaded screw indicated for long-term intra-bony applications. Additionally, the LEW Mini 0-ball Implant may be used for inter-radicular transitional applications: These devices will permit immediate splinting stability and long-term fixation of new or existing crown and bridge installations, for full or partial edentulism, and employing minimally invasive surgical intervention. The 2.0mm, 2.5 mm, and 3.0 mm diameter are intended to support single or multi-unit restorations in both long-term and temporary applications throughout the maxillary and mandibular arches.

Source page: https://510kreport.com/device/K121707
Methodology: https://510kreport.com/methodology