# K173965: Implant Planning Software

- Pathway: 510(k) (Traditional)
- Applicant: Inteware Co., Ltd.
- Decided: Oct 26, 2018 after 301 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Implant Planning is a software package specifically designed and developed to enable dentists to plan and perform virtual implant surgery prior to actual surgery. Implant Planning supports surgical planning for fully or partially edentulous patient’s case.

Source page: https://510kreport.com/device/K173965
Methodology: https://510kreport.com/methodology