510(k) · Cleared
ClearedImplant Studio 2015
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3Shape Medical A/S · LLZ System, Image Processing, Radiological
Cleared on Dec 4, 2015 as substantially equivalent to K110300 (Materialise Dental NV, 2011) and 2 other predicates after a 130-day review. Its family tree reaches back 8 generations to 1996. 7 later devices descend from it.
- Decided
- Dec 4, 2015
- Review
- 130 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K954678 (1996). 14 ancestors in all, the oldest K924810 (1993). 7 later devices descend from it, 5 citing it directly.
- 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 backK141570 Implant Studio3Shape Medical A/S · 2014
- This deviceK152078 Implant Studio 20153Shape Medical A/S · 2015
- Descendant · cites it directly · 2 of its ownK173041 3DIEMME RealGUIDE3Diemme, Ltd. · 2018
- Descendant · cites it directly · 1 of its ownK183458 exoplan 2.3Exocad GmbH · 2019
- Descendant · cites it directly · 1 of its ownK180629 DentiqGuide3D Industrial Imaging Co., Ltd. · 2018
- Descendant · cites it directly · 0 of its ownK253902 RealGUIDE3DIEMME SRL · 2026
- Descendant · 2 generations on · 0 of its ownK213302 exoplanExocad GmbH · 2022 · Recalled
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K1730413DIEMME RealGUIDE3Diemme, Ltd. · 2018 · cites it directly2descendants
- K183458exoplan 2.3Exocad GmbH · 2019 · cites it directly1descendant
- K180629DentiqGuide3D Industrial Imaging Co., Ltd. · 2018 · cites it directly1descendant
- K253902RealGUIDE3DIEMME SRL · 2026 · cites it directly0descendants
- K213302exoplanExocad GmbH · 2022 · 2 generations on0descendants
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 | K141570 | Implant Studio | 3Shape Medical A/S | 2014 | — |
| 0 (this device) | K152078 | Implant Studio 2015 | 3Shape Medical A/S | 2015 | — |
| +1 | K173041 | 3DIEMME RealGUIDE | 3Diemme, Ltd. | 2018 | — |
| +1 | K183458 | exoplan 2.3 | Exocad GmbH | 2019 | — |
| +1 | K180629 | DentiqGuide | 3D Industrial Imaging Co., Ltd. | 2018 | — |
| +1 | K253902 | RealGUIDE | 3DIEMME SRL | 2026 | — |
| +2 | K213302 | exoplan | Exocad GmbH | 2022 | 1 |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 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? (3)
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 |
|---|---|---|---|
| * | K110300 | Simplant 2011Summary page 4…: LLZ Predicate Device The 3Shape Implant Studio™ 2015-1 Software still has the same intended uses and major functions as Dentsply Simplant 2011 (K110300) and Straumann AG coDiagnostix (K130724). Furthermore the 510(k) is submitted to modify a legally marketed device, the indicatio… | 2011 |
| * | K130724 | Codiagnostix Implant Planning SoftwareSummary page 4…evice The 3Shape Implant Studio™ 2015-1 Software still has the same intended uses and major functions as Dentsply Simplant 2011 (K110300) and Straumann AG coDiagnostix (K130724). Furthermore the 510(k) is submitted to modify a legally marketed device, the indications for use of the proposed device are un… | 2013 |
| * | K141570 | Implant StudioSummary page 4…roposed device are unchanged and fundamental scientific technology of the proposed device is unchanged from the previous legally marketed device (Implant Studio 2014-1 – K141570). Testing demonstrates the implementation functions as intended, and differences between the Device and the predicates do not ra… | 2014 |
What descends from it? (7)
5 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 19 years and passes through 6 companies; a new generation was cleared every 2.1 years on median.
- 1 of the 14 ancestors has a recall of any class.
- Of its descendants, K173041 (3Diemme, Ltd., 2018) has gone furthest, with 2 descendants of its own.
- 8 other devices also cite its predicate K110300.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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?
Implant Studio™ is indicated for use as a medical front-end software that can be used by medically trained professionals for the purpose of visualizing gray value images. It is intended for use as a pre-operative planning software for the placement of dental implant(s) based on imported CT image data, optionally aligned to an optical 3D surface scan. Virtual Crowns can be used for optimized implant positioning under the prosthetic aspect. The digital…
Read the full statement (137 words)
Implant Studio™ is indicated for use as a medical front-end software that can be used by medically trained professionals for the purpose of visualizing gray value images. It is intended for use as a pre-operative planning software for the placement of dental implant(s) based on imported CT image data, optionally aligned to an optical 3D surface scan. Virtual Crowns can be used for optimized implant positioning under the prosthetic aspect. The digital three dimensional model of a surgical guide for a guided surgery can be designed based on the approved implant position. This 3D data can be exported to manufacture a separate physical product.
Indications of the dental implants do not change with guided surgery compared to conventional surgery.
Use of the software requires that the user has the necessary medical training in implantology and surgical dentistry.
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/K152078 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152078: Implant Studio 2015.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152078
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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