# K243066: Dental Implants and Abutments

- Pathway: 510(k) (Traditional)
- Applicant: Ditron Dental, Ltd.
- Decided: Dec 16, 2024 after 80 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: 15 generations back to K960026 (1996). 201 ancestors in all.
No later device cites it as a predicate yet.
0 of 202 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 6.

## 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 chewing function of patients with fully or partially edentulous: Two stages: MPI, ULT, API, CPI, MPC, APC, CPC and UPC models One stage: OPI and TPI models The 3.3mm and 3.0mm diameter implants (OPI and TPI, MPI and API) are intended only for the incisors and cuspids of the maxilla and mandible. They are also indicated for denture stabilization using multiple implants. The Two stages and One stage implants are indicated for temporary or long-term use. They 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, TPI, MPC, APC, CPC and UPC models are indicated for immediate loading (except for MPI, and APl 6mm length) in single- and multi-tooth restoration, when good primary stability is achieved and 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. The Temporary Titanium and PEEK Abutments are indicated to be used on Ditron implants to provide temporary support for prosthesis structure for up to 6 months. They can be used in one or two stage procedures and also immediate load when there is good primary stability.

Source page: https://510kreport.com/device/K243066
Methodology: https://510kreport.com/methodology