# K230012: Atomica Planner

- Pathway: 510(k) (Traditional)
- Applicant: Atomica Technology, Inc.
- Decided: Feb 2, 2023 after 30 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
Longest line of descent: 8 generations back to K954678 (1996). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202256: 3Shape Implant Studio, 3Shape Medical A/S (2020) Summary page 4.

## Indications for use
"Atomica Planner" is stand-alone software indicated for use by highly qualified dental professionals in the preoperative simulation-based planning of implant placements, and designing patients' 3D model surgical guides to support dental treatment surgeries (such as teeth replacement for Adult patients with missing/damaged teeth; taking into account dental functional & esthetic aspects). "Atomica Planner" image-processing functions & tools provide users with 2D/3D visualization & segmentation for imported medical digital imaging (DICOM) datasets (acquired originally by optical/medical scanners, such as CT) to enhance the image-guided detection of suitable implant placements based on the evaluation of intraoral surrounding tissue. System users can also export patient plan dataset output with final surgical instructions PDF report, and the designed surgical guide 3D models in the imaging (STL) file format which is compatible with a wide range of 3rd parties manufacturing systems. system is intended to be used only by highly-qualified dental professionals with sufficient training in implantology & surgical dentistry as well as practical experience with using digital imaging technologies and in an environment suitable for reading diagnostic dental DICOM data sets.

Source page: https://510kreport.com/device/K230012
Methodology: https://510kreport.com/methodology