# K212173: HDH Treatment Planning System

- Pathway: 510(k) (Traditional)
- Applicant: Cdb Corporation
- Decided: Jan 25, 2022 after 197 days
- Product code: PNN (Orthodontic Software)
- Device class: 2
- Regulation: 21 CFR 872.5470
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K082207 (2009). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152086: 3Shape Ortho System, 3Shape A/S (2016) Summary page 5.

## Indications for use
The HDH Treatment Planning System is intended for use as a medical front-end device providing tools for management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual design of a series of dental casts, which may be used for sequential aligner trays or retainers, based on 3D models of the patient's dentition. The use of the HDH Treatment Planning System requires the user to have the necessary training and domain knowledge in the practice of orthodontics, as well to have received a dedicated training in the use of the software.

Source page: https://510kreport.com/device/K212173
Methodology: https://510kreport.com/methodology