510(k) · Cleared
ClearedInvivo Dental
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Anatomage, Inc. · LLZ System, Image Processing, Radiological
Cleared on Feb 1, 2013 as substantially equivalent to K070803 (Anatomage, Inc., 2007) and 1 other predicate after a 78-day review. Its family tree reaches back 6 generations to 1996. 24 later devices descend from it.
- Decided
- Feb 1, 2013
- Review
- 78 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K954678 (1996). 14 ancestors in all, the oldest K924810 (1993). 24 later devices descend from it, 5 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 backK070803 InvivodentalAnatomage, Inc. · 2007
- This deviceK123519 Invivo DentalAnatomage, Inc. · 2013
- Descendant · cites it directly · 14 of its ownK140713 Planmeca RomexisPlanmeca Oy · 2014
- Descendant · 2 generations on · 13 of its ownK162799 CliniviewPalodex Group OY · 2017
- Descendant · 3 generations on · 10 of its ownK203156 DTX Studio ClinicNobel Biocare AB · 2020
- Descendant · 4 generations on · 9 of its ownK213562 DTX Studio Clinic 3.0Nobel Biocare AB · 2022
- Descendant · 5 generations on · 6 of its ownK233925 Relu CreatorRelu BV · 2024
Showing 5 of 24 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 24 · See all- K140713Planmeca RomexisPlanmeca Oy · 2014 · cites it directly14descendants
- K162799CliniviewPalodex Group OY · 2017 · 2 generations on13descendants
- K203156DTX Studio ClinicNobel Biocare AB · 2020 · 3 generations on10descendants
- K213562DTX Studio Clinic 3.0Nobel Biocare AB · 2022 · 4 generations on9descendants
- K233925Relu CreatorRelu BV · 2024 · 5 generations on6descendants
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 | K070803 | Invivodental | Anatomage, Inc. | 2007 | — |
| 0 (this device) | K123519 | Invivo Dental | Anatomage, Inc. | 2013 | — |
| +1 | K140713 | Planmeca Romexis | Planmeca Oy | 2014 | — |
| +2 | K162799 | Cliniview | Palodex Group OY | 2017 | — |
| +3 | K203156 | DTX Studio Clinic | Nobel Biocare AB | 2020 | — |
| +4 | K213562 | DTX Studio Clinic 3.0 | Nobel Biocare AB | 2022 | — |
| +5 | K233925 | Relu Creator | Relu BV | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 2 | 0 |
| 1997 | 1 | 0 |
| 2004 | 2 | 0 |
| 2006 | 2 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 3 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 6 | 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 |
|---|---|---|---|
| * | K070803 | InvivodentalSummary page 2…implants, orthodontic planning and surgical treatments. This device is not indicated for mammography use. Equivalent Devices K070803 Anatomage, InVivoDental K081347 IMTEC ILUMA Vision v2.O Technological Characteristi… | 2007 |
| * | K081347 | Iluma VisionSummary page 2…This device is not indicated for mammography use. Equivalent Devices K070803 Anatomage, InVivoDental K081347 IMTEC ILUMA Vision v2.O Technological Characteristic InVivoDental and the predicate devices are standalone software.… | 2008 |
What descends from it? (24)
See all 245 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 4 companies; a new generation was cleared every 2.5 years on median.
- 1 of the 14 ancestors has a recall of any class.
- Of its descendants, K140713 (Planmeca Oy, 2014) has gone furthest, with 14 descendants of its own.
- 3 other devices also cite its predicate K070803.
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?
InVivoDental is a software application used for the display and 3D visualization of medical image files from scanning devices, such as CT, MRT, or 3D Ultrasound. It is intended for use by radiologists, clinicians, referring physicians and other qualified individuals to retrieve, process, render, review, store, print, assist in diagnosis and distribute images, utilizing standard PC hardware. Additionally, InVivoDental is a preoperative software application used for the simulation and evaluation of dental implants, orthodontic planning and surgical treatments.
This device is not indicated for mammography use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123519 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123519: Invivo Dental.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123519
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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