510(k) · Cleared
Recalled · Class II · 2023exoplan
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Exocad GmbH · LLZ System, Image Processing, Radiological
Cleared on May 3, 2022 as substantially equivalent to K183458 (Exocad GmbH, 2019) after a 211-day review. Its family tree reaches back 10 generations to 1996. It has been recalled once.
- Decided
- May 3, 2022
- Review
- 211 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 10 generations to K954678 (1996). 16 ancestors in all, the oldest K924810 (1993). No later device cites it as a predicate yet.
- Root · 10 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 6 generations between
- 3 generations backK141570 Implant Studio3Shape Medical A/S · 2014
- 2 generations backK152078 Implant Studio 20153Shape Medical A/S · 2015
- 1 generation backK183458 exoplan 2.3Exocad GmbH · 2019
- This deviceK213302 exoplanExocad GmbH · 2022
Show all 10 generations
- Root · 10 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 9 generations backK980648 Pro VisionAlgotec Systems, Ltd. · 1998
- 8 generations backK992654 Plug 'N View 3D, Version 1.0Voxar Limited · 1999
- 7 generations backK013878 Cybermed, Inc., V-WorksCybermed, Inc. · 2001
- 6 generations backK053155 VimplantCybermed, Inc. · 2005
- 5 generations backK071636 Codiagnostix (R) 5.72Ivs Solutions AG · 2007 · Recalled
- 4 generations backK130724 Codiagnostix Implant Planning SoftwareStraumann USA · 2013
- 3 generations backK141570 Implant Studio3Shape Medical A/S · 2014
- 2 generations backK152078 Implant Studio 20153Shape Medical A/S · 2015
- 1 generation backK183458 exoplan 2.3Exocad GmbH · 2019
- This deviceK213302 exoplanExocad GmbH · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K954678 | Pro Vision | Algotec Systems, Ltd. | 1996 | — |
| −9 | K980648 | Pro Vision | Algotec Systems, Ltd. | 1998 | — |
| −8 | K992654 | Plug 'N View 3D, Version 1.0 | Voxar Limited | 1999 | — |
| −7 | K013878 | Cybermed, Inc., V-Works | Cybermed, Inc. | 2001 | — |
| −6 | K053155 | Vimplant | Cybermed, Inc. | 2005 | — |
| −5 | K071636 | Codiagnostix (R) 5.72 | Ivs Solutions AG | 2007 | 2 |
| −4 | K130724 | Codiagnostix Implant Planning Software | Straumann USA | 2013 | — |
| −3 | K141570 | Implant Studio | 3Shape Medical A/S | 2014 | — |
| −2 | K152078 | Implant Studio 2015 | 3Shape Medical A/S | 2015 | — |
| −1 | K183458 | exoplan 2.3 | Exocad GmbH | 2019 | — |
| 0 (this device) | K213302 | exoplan | Exocad GmbH | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 2 | 0 |
| 1997 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2011 | 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 |
|---|---|---|---|
| * | K183458 | exoplan 2.3Summary page 4…fication Product Code: LLZ Predicate Device exoplan has been compared to the following predicate legally marketed device: 510(k) Number: K183458 Device name: exoplan 2.3 Manufacturer: exocad GmbH, Julius-Reiber-Str. 37, 64293 Darmstadt Referenc… | 2019 |
| † | K202256 | 3Shape Implant Studio | 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 17, 2023 | Class II | Z-2633-2023 | Software design | A software library filtering error has been discovered which occurs when users are using the Step-by-Step Full Drill Protocol export functionality of exoplan 3.1 Rijeka. When a guided surgery treatment approach is selected, along with a… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 26 years and passes through 7 companies; a new generation was cleared every 2.5 years on median.
- 1 of the 16 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. 2022, 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?
exoplan is a medical software, intended to support the pre-operative planning of dental implants using the visualization of the implant placement within images of the patient’s anatomy. The process is based on CT/CBCT data sets originating from other medical devices, and can be supported by optical scan(s) of the patient’s anatomy as well as a virtual prosthetic proposal. exoplan allows the design of surgical guides to support the placement of endosseous…
Read the full statement (220 words)
exoplan is a medical software, intended to support the pre-operative planning of dental implants using the visualization of the implant placement within images of the patient’s anatomy. The process is based on CT/CBCT data sets originating from other medical devices, and can be supported by optical scan(s) of the patient’s anatomy as well as a virtual prosthetic proposal. exoplan allows the design of surgical guides to support the placement of endosseous dental implants in guided surgery. The design of surgical guides is based on 3D surface data representing the preoperative situation and approved implant positions. Alternatively, instead of optical surface data a second CBCT/CT dataset can be used. The software exports the planning and design results as geometrical data and a digital 3D model of the surgical guide to support the manufacture of a separate physical product.
exoplan does not extend or change indications of dental implants. Usage of a surgical guide designed with the software does not change the necessary due diligence required compared to conventional (non-guided) surgery.
The software is intended to be used only by dental professionals with sufficient medical training in dental implantology and surgical dentistry in office environments suitable for reading diagnostic dental DICOM data sets. exoplan shall not be used for any purpose other than planning dental implant placement or design of surgical guides.
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/K213302 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213302: exoplan.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213302
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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