510(k) · Cleared
ClearedDTX Studio Clinic
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nobel Biocare AB · LLZ System, Image Processing, Radiological
Cleared on Nov 20, 2020 as substantially equivalent to K162799 (Palodex Group OY, 2017) after a 29-day review. Its family tree reaches back 9 generations to 1996. 10 later devices descend from it.
- Decided
- Nov 20, 2020
- Review
- 29 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K954678 (1996). 26 ancestors in all, the oldest K924810 (1993). 10 later devices descend from it, 1 citing it directly.
- Root · 9 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 5 generations between
- 3 generations backK123519 Invivo DentalAnatomage, Inc. · 2013
- 2 generations backK140713 Planmeca RomexisPlanmeca Oy · 2014
- 1 generation backK162799 CliniviewPalodex Group OY · 2017
- This deviceK203156 DTX Studio ClinicNobel Biocare AB · 2020
- Descendant · cites it directly · 9 of its ownK213562 DTX Studio Clinic 3.0Nobel Biocare AB · 2022
- Descendant · 2 generations on · 6 of its ownK233925 Relu CreatorRelu BV · 2024
- Descendant · 3 generations on · 3 of its ownK243989 Second Opinion® 3DPearl, Inc. · 2025
- Descendant · 3 generations on · 1 of its ownK260785 DS Core CBCT AnatomyDentsply Sirona · 2026
- Descendant · 2 generations on · 1 of its ownK231898 DTX Studio Clinic (4.0)Nobel Biocare AB · 2023
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 backK070803 InvivodentalAnatomage, Inc. · 2007
- 3 generations backK123519 Invivo DentalAnatomage, Inc. · 2013
- 2 generations backK140713 Planmeca RomexisPlanmeca Oy · 2014
- 1 generation backK162799 CliniviewPalodex Group OY · 2017
- This deviceK203156 DTX Studio ClinicNobel Biocare AB · 2020
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K213562DTX Studio Clinic 3.0Nobel Biocare AB · 2022 · cites it directly9descendants
- K233925Relu CreatorRelu BV · 2024 · 2 generations on6descendants
- K243989Second Opinion® 3DPearl, Inc. · 2025 · 3 generations on3descendants
- K260785DS Core CBCT AnatomyDentsply Sirona · 2026 · 3 generations on1descendant
- K231898DTX Studio Clinic (4.0)Nobel Biocare AB · 2023 · 2 generations on1descendant
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 | K070803 | Invivodental | Anatomage, Inc. | 2007 | — |
| −3 | K123519 | Invivo Dental | Anatomage, Inc. | 2013 | — |
| −2 | K140713 | Planmeca Romexis | Planmeca Oy | 2014 | — |
| −1 | K162799 | Cliniview | Palodex Group OY | 2017 | — |
| 0 (this device) | K203156 | DTX Studio Clinic | Nobel Biocare AB | 2020 | — |
| +1 | K213562 | DTX Studio Clinic 3.0 | Nobel Biocare AB | 2022 | — |
| +2 | K233925 | Relu Creator | Relu BV | 2024 | — |
| +3 | K243989 | Second Opinion® 3D | Pearl, Inc. | 2025 | — |
| +3 | K260785 | DS Core CBCT Anatomy | Dentsply Sirona | 2026 | — |
| +2 | K231898 | DTX Studio Clinic (4.0) | Nobel Biocare AB | 2023 | — |
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 |
| 2002 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 4 | 0 |
| 2008 | 1 | 0 |
| 2014 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K162799 | CliniviewSummary page 4…ss: 2 Product Code: LLZ III. Predicate Device Substantial equivalence is claimed to the following device: Main predicate Predicate Device: CliniView Predicate 510(k): K162799 Compay: Palodex Group Classification name: System, Image Processing, Radiological Regulatory Class: 2 Regulation number: 892.2050… | 2017 |
| † | K183676 | DentiqAir | 2019 |
| † | K163122 | NobelClinician, DTX Studio implant | 2017 |
What descends from it? (10)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K213562 | DTX Studio Clinic 3.0 | 2022 | 9 |
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 2.5 years on median.
- 2 of the 26 ancestors have a recall of any class.
- Of its descendants, K213562 (Nobel Biocare AB, 2022) has gone furthest, with 9 descendants of its own.
- 2 other devices also cite its predicate K162799.
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?
DTX Studio Clinic is a software program for the acquisition, management, transfer and analysis of dental and craniomaxillofacial image information, and can be used to provide design input for dental restorative solutions. It displays and enhances digital images from various sources to support the diagnostic process and treatment planning. It stores and provides these images within the system or across computer systems at different locations.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K203156 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203156: DTX Studio Clinic.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203156
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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