510(k) · Cleared
ClearedDentiqGuide
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3D Industrial Imaging Co., Ltd. · LLZ System, Image Processing, Radiological
Cleared on Jul 19, 2018 as substantially equivalent to K152078 (3Shape Medical A/S, 2015) after a 132-day review. Its family tree reaches back 9 generations to 1996. 1 later device descends from it.
- Decided
- Jul 19, 2018
- Review
- 132 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K954678 (1996). 15 ancestors in all, the oldest K924810 (1993). 1 later device descends from it, 1 citing it directly.
- Root · 9 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 5 generations between
- 3 generations backK130724 Codiagnostix Implant Planning SoftwareStraumann USA · 2013
- 2 generations backK141570 Implant Studio3Shape Medical A/S · 2014
- 1 generation backK152078 Implant Studio 20153Shape Medical A/S · 2015
- This deviceK180629 DentiqGuide3D Industrial Imaging Co., Ltd. · 2018
- Descendant · cites it directly · 0 of its ownK200078 VARO Plan3D Industrial Imaging Co., Ltd. · 2020
Show all 9 generations
- Root · 9 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 8 generations backK980648 Pro VisionAlgotec Systems, Ltd. · 1998
- 7 generations backK992654 Plug 'N View 3D, Version 1.0Voxar Limited · 1999
- 6 generations backK013878 Cybermed, Inc., V-WorksCybermed, Inc. · 2001
- 5 generations backK053155 VimplantCybermed, Inc. · 2005
- 4 generations backK071636 Codiagnostix (R) 5.72Ivs Solutions AG · 2007 · Recalled
- 3 generations backK130724 Codiagnostix Implant Planning SoftwareStraumann USA · 2013
- 2 generations backK141570 Implant Studio3Shape Medical A/S · 2014
- 1 generation backK152078 Implant Studio 20153Shape Medical A/S · 2015
- This deviceK180629 DentiqGuide3D Industrial Imaging Co., Ltd. · 2018
Most influential descendants
Showing 1 of 1 · See all- K200078VARO Plan3D Industrial Imaging Co., Ltd. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K954678 | Pro Vision | Algotec Systems, Ltd. | 1996 | — |
| −8 | K980648 | Pro Vision | Algotec Systems, Ltd. | 1998 | — |
| −7 | K992654 | Plug 'N View 3D, Version 1.0 | Voxar Limited | 1999 | — |
| −6 | K013878 | Cybermed, Inc., V-Works | Cybermed, Inc. | 2001 | — |
| −5 | K053155 | Vimplant | Cybermed, Inc. | 2005 | — |
| −4 | K071636 | Codiagnostix (R) 5.72 | Ivs Solutions AG | 2007 | 2 |
| −3 | K130724 | Codiagnostix Implant Planning Software | Straumann USA | 2013 | — |
| −2 | K141570 | Implant Studio | 3Shape Medical A/S | 2014 | — |
| −1 | K152078 | Implant Studio 2015 | 3Shape Medical A/S | 2015 | — |
| 0 (this device) | K180629 | DentiqGuide | 3D Industrial Imaging Co., Ltd. | 2018 | — |
| +1 | K200078 | VARO Plan | 3D Industrial Imaging Co., Ltd. | 2020 | — |
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 |
|---|---|---|
| 2020 | 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 |
|---|---|---|---|
| * | K152078 | Implant Studio 2015Summary page 5…are requires that the user has the necessary medical training in implantology and surgical dentistry. 9. Predicate Device: Implant Studio™ by 3Shape Medical A/S (K152078) (LLZ, 21 CFR 892.2050) 10. Substantial Equivalence: The DentiqGuide described in this 510(k) has the same intended use and… | 2015 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K200078 | VARO Plan | 2020 | 0 |
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 22 years and passes through 7 companies; a new generation was cleared every 2.1 years on median.
- 1 of the 15 ancestors has a recall of any class.
- Of its descendants, K200078 (3D Industrial Imaging Co., Ltd., 2020) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K152078.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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?
DentiqGuide Software is a stand-alone Windows-based software application to support the treatment planning for dental implantation. It is designed for qualified dental practitioners, including dentists and lab technicians. The software imports the medical image dataset of the patient in DICOM format from medical CT or dental CBCT scanners for pre-operative planning and simulation of dental placement. It is intended for use as pre-operative planning…
Read the full statement (165 words)
DentiqGuide Software is a stand-alone Windows-based software application to support the treatment planning for dental implantation. It is designed for qualified dental practitioners, including dentists and lab technicians. The software imports the medical image dataset of the patient in DICOM format from medical CT or dental CBCT scanners for pre-operative planning and simulation of dental placement.
It is intended for use as 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/K180629 · printed Nov 4, 2026
Cite this page
510(k) Report. “K180629: DentiqGuide.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K180629
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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