510(k) · Cleared
ClearedDTX Studio Clinic 3.0
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 Mar 25, 2022 as substantially equivalent to K203156 (Nobel Biocare AB, 2020) after a 136-day review. Its family tree reaches back 10 generations to 1996. 9 later devices descend from it.
- Decided
- Mar 25, 2022
- Review
- 136 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K954678 (1996). 27 ancestors in all, the oldest K924810 (1993). 9 later devices descend from it, 2 citing it directly.
- Root · 10 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 6 generations between
- 3 generations backK140713 Planmeca RomexisPlanmeca Oy · 2014
- 2 generations backK162799 CliniviewPalodex Group OY · 2017
- 1 generation backK203156 DTX Studio ClinicNobel Biocare AB · 2020
- This deviceK213562 DTX Studio Clinic 3.0Nobel Biocare AB · 2022
- Descendant · cites it directly · 6 of its ownK233925 Relu CreatorRelu BV · 2024
- Descendant · 2 generations on · 3 of its ownK243989 Second Opinion® 3DPearl, Inc. · 2025
- Descendant · 2 generations on · 1 of its ownK260785 DS Core CBCT AnatomyDentsply Sirona · 2026
- Descendant · cites it directly · 1 of its ownK231898 DTX Studio Clinic (4.0)Nobel Biocare AB · 2023
- Descendant · 3 generations on · 0 of its ownK262127 DS Core CBCT AnatomyDentsply Sirona · 2026
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 backK070803 InvivodentalAnatomage, Inc. · 2007
- 4 generations backK123519 Invivo DentalAnatomage, Inc. · 2013
- 3 generations backK140713 Planmeca RomexisPlanmeca Oy · 2014
- 2 generations backK162799 CliniviewPalodex Group OY · 2017
- 1 generation backK203156 DTX Studio ClinicNobel Biocare AB · 2020
- This deviceK213562 DTX Studio Clinic 3.0Nobel Biocare AB · 2022
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K233925Relu CreatorRelu BV · 2024 · cites it directly6descendants
- K243989Second Opinion® 3DPearl, Inc. · 2025 · 2 generations on3descendants
- K260785DS Core CBCT AnatomyDentsply Sirona · 2026 · 2 generations on1descendant
- K231898DTX Studio Clinic (4.0)Nobel Biocare AB · 2023 · cites it directly1descendant
- K262127DS Core CBCT AnatomyDentsply Sirona · 2026 · 3 generations on0descendants
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 | K070803 | Invivodental | Anatomage, Inc. | 2007 | — |
| −4 | K123519 | Invivo Dental | Anatomage, Inc. | 2013 | — |
| −3 | K140713 | Planmeca Romexis | Planmeca Oy | 2014 | — |
| −2 | K162799 | Cliniview | Palodex Group OY | 2017 | — |
| −1 | K203156 | DTX Studio Clinic | Nobel Biocare AB | 2020 | — |
| 0 (this device) | K213562 | DTX Studio Clinic 3.0 | Nobel Biocare AB | 2022 | — |
| +1 | K233925 | Relu Creator | Relu BV | 2024 | — |
| +2 | K243989 | Second Opinion® 3D | Pearl, Inc. | 2025 | — |
| +2 | K260785 | DS Core CBCT Anatomy | Dentsply Sirona | 2026 | — |
| +1 | K231898 | DTX Studio Clinic (4.0) | Nobel Biocare AB | 2023 | — |
| +3 | K262127 | DS Core CBCT Anatomy | Dentsply Sirona | 2026 | — |
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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K203156 | DTX Studio ClinicSummary page 4…t Code: LLZ III. Predicate Device Substantial equivalence is claimed to the following devices: Primary Predicate: Predicate Device: DTX Studio Clinic Predicate 510(k): K203156 Company: Nobel Biocare AB Common or Usual Name: Medical Image Management and Processing System Classification Name: System, Image… | 2020 |
| † | K123519 | Invivo Dental | 2013 |
What descends from it? (9)
2 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 26 years and passes through 7 companies; a new generation was cleared every 2.5 years on median.
- 2 of the 27 ancestors have a recall of any class.
- Of its descendants, K233925 (Relu BV, 2024) has gone furthest, with 6 descendants of its own.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K213562 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213562: DTX Studio Clinic 3.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213562
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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