510(k) · Cleared
ClearedPlanmeca Romexis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Planmeca Oy · LLZ System, Image Processing, Radiological
Cleared on Jun 16, 2014 as substantially equivalent to K123519 (Anatomage, Inc., 2013) and 1 other predicate after an 87-day review. Its family tree reaches back 7 generations to 1996. 14 later devices descend from it.
- Decided
- Jun 16, 2014
- Review
- 87 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K954678 (1996). 19 ancestors in all, the oldest K924810 (1993). 14 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 6 generations backK980648 Pro VisionAlgotec Systems, Ltd. · 1998
- 5 generations backK992654 Plug 'N View 3D, Version 1.0Voxar Limited · 1999
- 4 generations backK013878 Cybermed, Inc., V-WorksCybermed, Inc. · 2001
- 3 generations backK053155 VimplantCybermed, Inc. · 2005
- 2 generations backK070803 InvivodentalAnatomage, Inc. · 2007
- 1 generation backK123519 Invivo DentalAnatomage, Inc. · 2013
- This deviceK140713 Planmeca RomexisPlanmeca Oy · 2014
- Descendant · cites it directly · 13 of its ownK162799 CliniviewPalodex Group OY · 2017
- Descendant · 2 generations on · 10 of its ownK203156 DTX Studio ClinicNobel Biocare AB · 2020
- Descendant · 3 generations on · 9 of its ownK213562 DTX Studio Clinic 3.0Nobel Biocare AB · 2022
- Descendant · 4 generations on · 6 of its ownK233925 Relu CreatorRelu BV · 2024
- Descendant · 5 generations on · 3 of its ownK243989 Second Opinion® 3DPearl, Inc. · 2025
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K162799CliniviewPalodex Group OY · 2017 · cites it directly13descendants
- K203156DTX Studio ClinicNobel Biocare AB · 2020 · 2 generations on10descendants
- K213562DTX Studio Clinic 3.0Nobel Biocare AB · 2022 · 3 generations on9descendants
- K233925Relu CreatorRelu BV · 2024 · 4 generations on6descendants
- K243989Second Opinion® 3DPearl, Inc. · 2025 · 5 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K954678 | Pro Vision | Algotec Systems, Ltd. | 1996 | — |
| −6 | K980648 | Pro Vision | Algotec Systems, Ltd. | 1998 | — |
| −5 | K992654 | Plug 'N View 3D, Version 1.0 | Voxar Limited | 1999 | — |
| −4 | K013878 | Cybermed, Inc., V-Works | Cybermed, Inc. | 2001 | — |
| −3 | K053155 | Vimplant | Cybermed, Inc. | 2005 | — |
| −2 | K070803 | Invivodental | Anatomage, Inc. | 2007 | — |
| −1 | K123519 | Invivo Dental | Anatomage, Inc. | 2013 | — |
| 0 (this device) | K140713 | Planmeca Romexis | Planmeca Oy | 2014 | — |
| +1 | K162799 | Cliniview | Palodex Group OY | 2017 | — |
| +2 | K203156 | DTX Studio Clinic | Nobel Biocare AB | 2020 | — |
| +3 | K213562 | DTX Studio Clinic 3.0 | Nobel Biocare AB | 2022 | — |
| +4 | K233925 | Relu Creator | Relu BV | 2024 | — |
| +5 | K243989 | Second Opinion® 3D | Pearl, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 3 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2004 | 2 | 0 |
| 2006 | 3 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 4 | 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 |
|---|---|---|---|
| * | K123519 | Invivo DentalSummary page 2…nts and/or abutments. * Not intended for optically scanning intra-orally for use in orthodontics. * Not intended for mammography use. PREDICATE DEVICES K123519 Anatomage InVivoDental K061035 Teleyere Systems TigerView TECHNOLOGICAL CHARACTERISTIC… | 2013 |
| * | K061035 | Tigerview ProfessionalSummary page 2…ically scanning intra-orally for use in orthodontics. * Not intended for mammography use. PREDICATE DEVICES K123519 Anatomage InVivoDental K061035 Teleyere Systems TigerView TECHNOLOGICAL CHARACTERISTICS Both Planmeca Romexis and the predicate device InViv… | 2006 |
What descends from it? (14)
See all 141 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K162799 | Cliniview | 2017 | 13 |
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 18 years and passes through 5 companies; a new generation was cleared every 2.1 years on median.
- 1 of the 19 ancestors has a recall of any class.
- Of its descendants, K162799 (Palodex Group OY, 2017) has gone furthest, with 13 descendants of its own.
- 4 other devices also cite its predicate K123519.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
Planmeca Romexis is a medical imaging software, and is intended for use in dental and medical care as a tool for displaying and visualizing dental and medical 2D and 3D image files from imaging devices, such as projection radiography and CBCT. It is intended to retrieve, process, render, diagnose, review, store, print, and distribute images. It is also a preoperative software application used for the simulation and evaluation of dental implants. The…
Read the full statement (174 words)
Planmeca Romexis is a medical imaging software, and is intended for use in dental and medical care as a tool for displaying and visualizing dental and medical 2D and 3D image files from imaging devices, such as projection radiography and CBCT. It is intended to retrieve, process, render, diagnose, review, store, print, and distribute images.
It is also a preoperative software application used for the simulation and evaluation of dental implants. The software includes monitoring features for Planmeca devices for maintenance purposes. It is designed to work as a stand-alone or as an accessory to Planmeca imaging and Planmeca dental unit products in a standard PC. The software is for use by authorized healthcare professionals.
Planmeca Romexis software is:
* Not intended for capturing optical impressions for dental restorations.
* Not intended for optically scanning stone models and impressions for dental restorations.
* Not intended for optically scanning intraoral preparations for use in designing implants and/or abutments.
* Not intended for optically scanning intra-orally for use in orthodontics.
* Not intended for mammography use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140713 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140713: Planmeca Romexis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140713
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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