510(k) · Cleared
ClearedCodiagnostix Implant Planning Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Straumann USA · LLZ System, Image Processing, Radiological
Cleared on Jun 28, 2013 as substantially equivalent to K071636 (Ivs Solutions AG, 2007) after a 102-day review. Its family tree reaches back 6 generations to 1996. 15 later devices descend from it.
- Decided
- Jun 28, 2013
- Review
- 102 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K954678 (1996). 10 ancestors in all, the oldest K924810 (1993). 15 later devices descend from it, 7 citing it directly.
- Root · 6 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 5 generations backK980648 Pro VisionAlgotec Systems, Ltd. · 1998
- 4 generations backK992654 Plug 'N View 3D, Version 1.0Voxar Limited · 1999
- 3 generations backK013878 Cybermed, Inc., V-WorksCybermed, Inc. · 2001
- 2 generations backK053155 VimplantCybermed, Inc. · 2005
- 1 generation backK071636 Codiagnostix (R) 5.72Ivs Solutions AG · 2007 · Recalled
- This deviceK130724 Codiagnostix Implant Planning SoftwareStraumann USA · 2013
- Descendant · cites it directly · 8 of its ownK141570 Implant Studio3Shape Medical A/S · 2014
- Descendant · cites it directly · 7 of its ownK152078 Implant Studio 20153Shape Medical A/S · 2015
- Descendant · 2 generations on · 2 of its ownK173041 3DIEMME RealGUIDE3Diemme, Ltd. · 2018
- Descendant · cites it directly · 1 of its ownK202256 3Shape Implant Studio3Shape Medical A/S · 2020
- Descendant · 2 generations on · 1 of its ownK183458 exoplan 2.3Exocad GmbH · 2019
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K141570Implant Studio3Shape Medical A/S · 2014 · cites it directly8descendants
- K152078Implant Studio 20153Shape Medical A/S · 2015 · cites it directly7descendants
- K1730413DIEMME RealGUIDE3Diemme, Ltd. · 2018 · 2 generations on2descendants
- K2022563Shape Implant Studio3Shape Medical A/S · 2020 · cites it directly1descendant
- K183458exoplan 2.3Exocad GmbH · 2019 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K954678 | Pro Vision | Algotec Systems, Ltd. | 1996 | — |
| −5 | K980648 | Pro Vision | Algotec Systems, Ltd. | 1998 | — |
| −4 | K992654 | Plug 'N View 3D, Version 1.0 | Voxar Limited | 1999 | — |
| −3 | K013878 | Cybermed, Inc., V-Works | Cybermed, Inc. | 2001 | — |
| −2 | K053155 | Vimplant | Cybermed, Inc. | 2005 | — |
| −1 | K071636 | Codiagnostix (R) 5.72 | Ivs Solutions AG | 2007 | 2 |
| 0 (this device) | K130724 | Codiagnostix Implant Planning Software | Straumann USA | 2013 | — |
| +1 | K141570 | Implant Studio | 3Shape Medical A/S | 2014 | — |
| +1 | K152078 | Implant Studio 2015 | 3Shape Medical A/S | 2015 | — |
| +2 | K173041 | 3DIEMME RealGUIDE | 3Diemme, Ltd. | 2018 | — |
| +1 | K202256 | 3Shape Implant Studio | 3Shape Medical A/S | 2020 | — |
| +2 | K183458 | exoplan 2.3 | Exocad GmbH | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 2 | 0 |
| 1997 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 3 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K071636 | Codiagnostix (R) 5.72Summary page 1…planning software Classification Name: Image Processing System Regulation Number: §892.2050 Legally Marketed Device to which Equivalence is Claimed (Predicate Device) K071636, IVS coDiagnostiX Description of the Device coDiagnostiX Implant Planning Software is designed for diagnosis of 3dimensional data… | 2007 |
What descends from it? (15)
See all 157 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 17 years and passes through 5 companies; a new generation was cleared every 2.5 years on median.
- 1 of the 10 ancestors has a recall of any class.
- Of its descendants, K141570 (3Shape Medical A/S, 2014) has gone furthest, with 8 descendants of its own.
- 1 other device also cites its predicate K071636.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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?
coDiagnostiX is an implant planning and surgery planning software tool intended for use by dental professionals who have appropriate knowledge in dental implantology and surgical dentistry. This software reads imaging information output from medical scanners such as CT or DVT scanners. It allows pre-operative simulation and evaluation of patient anatomy and dental implant placement.
For automated manufacturing of drill guides in the dental laboratory environment. the coDiagnostiX software allows for export of data to 3D manufacturing systems. Alternatively, coDiagnostiX can provide printouts of template plans for the creation of surgical templates using a manually operated gonyX table.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K130724 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130724: Codiagnostix Implant Planning Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130724
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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