# K140728: Mpi - Molecular Precision Implant, Cpi - Cylindrical Precision Implant, Opi - One Piece Implant, Dental Abutments and PR

- Pathway: 510(k) (Traditional)
- Applicant: Ditron Precision, Ltd.
- Decided: Oct 17, 2014 after 207 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: 14 generations back to K960026 (1996). 200 ancestors in all.
6 later devices descend from it; 4 cite it directly.
0 of 207 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063364: Alpha Bio Dental Implant System, Alpha-Bio Tec, Ltd. (2007) Summary page 5.
- K112440: AB Dental Devices Implants and Accessories, A.B. Dental Devices, Ltd. (2012) Summary page 5.
- K121688: Multi-Unit Abutments with Angulations 17 and 30 for Tapered Implant System, Prismatik Dentalcraft, Inc. (2012) Summary page 5.

## Most influential descendants
- K203240: AccelX Abutments (2021), 2 descendants of its own
- K252585: ZENEX Implant System_R-System (2026), 1 descendant of its own
- K161497: Dental Implants and Abutments (2016), 1 descendant of its own
- K253334: ZENEX Implant System_Short (R-System) (2026), 0 descendants of its own
- K243066: Dental Implants and Abutments (2024), 0 descendants of its own

## Indications for use
Ditron's Dental Implants and Abutments are indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient’s chewing function. x Two stage: MPI, CPI models x One stage: OPI model One stage and One piece OPI 3.3 and 3.0 mm diameter implants are intended only for the incisors and cuspids of the maxilla and mandible. They are also indicated for denture stabilization using multiple implants. Two stage and One stage implants for temporary or long-term use: MPI, CPI, OPI are self- tapping titanium threaded screws indicated for long term intra bony applications. They permit immediate splint stability and long-term fixation of new or existing crown, bridge and prosthesis and protection of graft sites. MPI, CPI and OPI designs are indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading. MPI, CPI and OPI are indicated for immediate loading in single tooth restorations when good primary stability is achieved with appropriate occlusal loading. The 30-degree multi-unit abutments must be used within 45 degrees of parallelism for a splinted restoration. The 17-degree multi-unit abutments must be used within 32 degrees of parallelism for a splinted restoration.

Source page: https://510kreport.com/device/K140728
Methodology: https://510kreport.com/methodology