510(k) · Cleared
ClearedAtomica Planner
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Atomica Technology, Inc. · LLZ System, Image Processing, Radiological
Cleared on Feb 2, 2023 as substantially equivalent to K202256 (3Shape Medical A/S, 2020) after a 30-day review. Its family tree reaches back 8 generations to 1996.
- Decided
- Feb 2, 2023
- Review
- 30 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K954678 (1996). 12 ancestors in all, the oldest K924810 (1993). No later device cites it as a predicate yet.
- Root · 8 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 7 generations backK980648 Pro VisionAlgotec Systems, Ltd. · 1998
- 6 generations backK992654 Plug 'N View 3D, Version 1.0Voxar Limited · 1999
- 5 generations backK013878 Cybermed, Inc., V-WorksCybermed, Inc. · 2001
- 4 generations backK053155 VimplantCybermed, Inc. · 2005
- 3 generations backK071636 Codiagnostix (R) 5.72Ivs Solutions AG · 2007 · Recalled
- 2 generations backK130724 Codiagnostix Implant Planning SoftwareStraumann USA · 2013
- 1 generation backK202256 3Shape Implant Studio3Shape Medical A/S · 2020
- This deviceK230012 Atomica PlannerAtomica Technology, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K954678 | Pro Vision | Algotec Systems, Ltd. | 1996 | — |
| −7 | K980648 | Pro Vision | Algotec Systems, Ltd. | 1998 | — |
| −6 | K992654 | Plug 'N View 3D, Version 1.0 | Voxar Limited | 1999 | — |
| −5 | K013878 | Cybermed, Inc., V-Works | Cybermed, Inc. | 2001 | — |
| −4 | K053155 | Vimplant | Cybermed, Inc. | 2005 | — |
| −3 | K071636 | Codiagnostix (R) 5.72 | Ivs Solutions AG | 2007 | 2 |
| −2 | K130724 | Codiagnostix Implant Planning Software | Straumann USA | 2013 | — |
| −1 | K202256 | 3Shape Implant Studio | 3Shape Medical A/S | 2020 | — |
| 0 (this device) | K230012 | Atomica Planner | Atomica Technology, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 2 | 0 |
| 1997 | 1 | 0 |
| 2004 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LLZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LLZ device
- #1 K230955 syngo Application Softwarescore 21.5 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K202256 | 3Shape Implant StudioSummary page 4…Radiology 3. Predicate Device Trade Name/Product Name: 3Shape Implant Studio 510(k) Number: K202256 Manufacturer: 3Shape Medical A/S Regulatory Class: Clas… | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 27 years and passes through 7 companies; a new generation was cleared every 2.5 years on median.
- 1 of the 12 ancestors has a recall of any class.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · LLZ
58in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 2025
MAUDE reports naming product code LLZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 76 | 36 | 20 | 152 |
| 2008 | 94 | 52 | 32 | 154 |
| 2009 | 70 | 62 | 21 | 145 |
| 2010 | 51 | 98 | 17 | 145 |
| 2011 | 106 | 79 | 30 | 454 |
| 2012 | 82 | 87 | 12 | 266 |
| 2013 | 95 | 84 | 64 | 1,130 |
| 2014 | 78 | 89 | 6 | 15,631 |
| 2015 | 64 | 90 | 16 | 211 |
| 2016 | 82 | 90 | 12 | 290 |
| 2017 | 78 | 107 | 5 | 104 |
| 2018 | 104 | 105 | 7 | 72 |
| 2019 | 74 | 107 | 2 | 88 |
| 2020 | 81 | 115 | 6 | 82 |
| 2021 | 83 | 116 | 3 | 70 |
| 2022 | 65 | 137 | 4 | 28 |
| 2023 | 87 | 157 | 8 | 26 |
| 2024 | 62 | 131 | 6 | 42 |
| 2025 | 58 | 173 | 11 | 116 |
| 2026 | 45 | 110 | 14 | — |
What is it indicated for?
"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…
Read the full statement (177 words)
"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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230012 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230012: Atomica Planner.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230012
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026