510(k) · Cleared
ClearedVARO Plan
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 Apr 10, 2020 as substantially equivalent to K180629 (3D Industrial Imaging Co., Ltd., 2018) and 1 other predicate after an 87-day review. Its family tree reaches back 10 generations to 1996.
- Decided
- Apr 10, 2020
- Review
- 87 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
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 backK180629 DentiqGuide3D Industrial Imaging Co., Ltd. · 2018
- This deviceK200078 VARO Plan3D Industrial Imaging Co., Ltd. · 2020
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 backK180629 DentiqGuide3D Industrial Imaging Co., Ltd. · 2018
- This deviceK200078 VARO Plan3D Industrial Imaging Co., Ltd. · 2020
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 | K180629 | DentiqGuide | 3D Industrial Imaging Co., Ltd. | 2018 | — |
| 0 (this device) | 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 |
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? (2)
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 |
|---|---|---|---|
| * | K180629 | DentiqGuideSummary page 5…equires that the user has the necessary medical training in implantology and surgical dentistry. 05. Predicate Device Identification - Predicate device 1 510(k) Number: K180629 Device Name: Dentiq Guide Manufacturer: 3D Industrial Imaging Co. Ltd - Predicate device 2 510(k) Number: K152078 Device Name: I… | 2018 |
| * | K152078 | Implant Studio 2015Summary page 5…ice Identification - Predicate device 1 510(k) Number: K180629 Device Name: Dentiq Guide Manufacturer: 3D Industrial Imaging Co. Ltd - Predicate device 2 510(k) Number: K152078 Device Name: Implant Studio™ Manufacturer: 3Shape Medical A/S… | 2015 |
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 24 years and passes through 7 companies; a new generation was cleared every 2.1 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. 2020, 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?
VARO Plan 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 (166 words)
VARO Plan 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 as stated in the FDA summary.
https://510kreport.com/device/K200078 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200078: VARO Plan.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200078
Report an extraction error
Are you the manufacturer?
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