# K233231: Dental Implants and Abutments

- Pathway: 510(k) (Traditional)
- Applicant: Ditron Dental, Ltd.
- Decided: Apr 30, 2024 after 215 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: 16 generations back to K960026 (1996). 271 ancestors in all.
No later device cites it as a predicate yet.
0 of 272 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140728: Mpi - Molecular Precision Implant, Cpi - Cylindrical Precision Implant, Opi - One Piece Implant, Dental Abutments and PR, Ditron Precision, Ltd. (2014) Summary page 5.
- K161497: Dental Implants and Abutments, Ditron Precision, Ltd. (2016) Summary page 5.
- K203660: TRI-matrix Implant Line, Tri Dental Implants Int. AG (2021) Summary page 5.

## 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. * Two stage: MPI, ULT, API and CPI models * One stage: OPI and TPI models The 3.3 and 3.0mm diameter models for One stage OPI and TPI, Two stage MPI, Two stage and API 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, ULT, API, CPI, OPI and TPI 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, ULT, API, CPI, OPI and TPI designs are indicated for immediate loading (except for MPI and API in 6.0mm length) when good primary stability is achieved and with appropriate ocolusal loading. MPI, ULT, API, CPI, OPI and TPI are indicated for immediate loading (except for MPI and API in 6.0mm length) 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/K233231
Methodology: https://510kreport.com/methodology