510(k) · Cleared
ClearedDTX Studio Clinic (4.0)
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 Dec 8, 2023 as substantially equivalent to K221921 (Nobel Biocare AB, 2023) and 2 other predicates after a 163-day review. Its family tree reaches back 11 generations to 1996. 1 later device descends from it.
- Decided
- Dec 8, 2023
- Review
- 163 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 11 generations to K954678 (1996). 41 ancestors in all, the oldest K924810 (1993). 1 later device descends from it, 1 citing it directly.
- Root · 11 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 7 generations between
- 3 generations backK162799 CliniviewPalodex Group OY · 2017
- 2 generations backK203156 DTX Studio ClinicNobel Biocare AB · 2020
- 1 generation backK213562 DTX Studio Clinic 3.0Nobel Biocare AB · 2022
- This deviceK231898 DTX Studio Clinic (4.0)Nobel Biocare AB · 2023
- Descendant · cites it directly · 0 of its ownK252086 DTX Studio AssistNobel Biocare C/O Medicim NV · 2025
Show all 11 generations
- Root · 11 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 10 generations backK980648 Pro VisionAlgotec Systems, Ltd. · 1998
- 9 generations backK992654 Plug 'N View 3D, Version 1.0Voxar Limited · 1999
- 8 generations backK013878 Cybermed, Inc., V-WorksCybermed, Inc. · 2001
- 7 generations backK053155 VimplantCybermed, Inc. · 2005
- 6 generations backK070803 InvivodentalAnatomage, Inc. · 2007
- 5 generations backK123519 Invivo DentalAnatomage, Inc. · 2013
- 4 generations backK140713 Planmeca RomexisPlanmeca Oy · 2014
- 3 generations backK162799 CliniviewPalodex Group OY · 2017
- 2 generations backK203156 DTX Studio ClinicNobel Biocare AB · 2020
- 1 generation backK213562 DTX Studio Clinic 3.0Nobel Biocare AB · 2022
- This deviceK231898 DTX Studio Clinic (4.0)Nobel Biocare AB · 2023
Most influential descendants
Showing 1 of 1 · See all- K252086DTX Studio AssistNobel Biocare C/O Medicim NV · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K954678 | Pro Vision | Algotec Systems, Ltd. | 1996 | — |
| −10 | K980648 | Pro Vision | Algotec Systems, Ltd. | 1998 | — |
| −9 | K992654 | Plug 'N View 3D, Version 1.0 | Voxar Limited | 1999 | — |
| −8 | K013878 | Cybermed, Inc., V-Works | Cybermed, Inc. | 2001 | — |
| −7 | K053155 | Vimplant | Cybermed, Inc. | 2005 | — |
| −6 | K070803 | Invivodental | Anatomage, Inc. | 2007 | — |
| −5 | K123519 | Invivo Dental | Anatomage, Inc. | 2013 | — |
| −4 | K140713 | Planmeca Romexis | Planmeca Oy | 2014 | — |
| −3 | K162799 | Cliniview | Palodex Group OY | 2017 | — |
| −2 | K203156 | DTX Studio Clinic | Nobel Biocare AB | 2020 | — |
| −1 | K213562 | DTX Studio Clinic 3.0 | Nobel Biocare AB | 2022 | — |
| 0 (this device) | K231898 | DTX Studio Clinic (4.0) | Nobel Biocare AB | 2023 | — |
| +1 | K252086 | DTX Studio Assist | Nobel Biocare C/O Medicim NV | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 3 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 2000 | 1 | 0 |
| 2002 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 5 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2017 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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? (3)
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 |
|---|---|---|---|
| * | K221921 | DTX Studio Clinic 3.0Summary page 4…ber 892.2070 Product Code MYN I Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K221921 DTX Studio Clinic 3.0 (Focus Area Detection) MYN K213562 DTX Studio Clinic 3.0 LLZ K163122 NobelClinician®, DTX Studio Implant LL… | 2023 |
| * | K213562 | DTX Studio Clinic 3.0Summary page 4…te Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K221921 DTX Studio Clinic 3.0 (Focus Area Detection) MYN K213562 DTX Studio Clinic 3.0 LLZ K163122 NobelClinician®, DTX Studio Implant LLZ Device Description Summary 21 CFR 807.92(a)(4) DTX Stu… | 2022 |
| * | K163122 | NobelClinician, DTX Studio implantSummary page 4…dicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K221921 DTX Studio Clinic 3.0 (Focus Area Detection) MYN K213562 DTX Studio Clinic 3.0 LLZ K163122 NobelClinician®, DTX Studio Implant LLZ Device Description Summary 21 CFR 807.92(a)(4) DTX Studio™ Clinic is a software interfac… | 2017 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K252086 | DTX Studio Assist | 2025 | 0 |
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 27 years and passes through 7 companies; a new generation was cleared every 2.1 years on median.
- 5 of the 41 ancestors have a recall of any class.
- Of its descendants, K252086 (Nobel Biocare C/O Medicim NV, 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K221921.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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. It can be…
Read the full statement (153 words)
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.
It can be used to support guided implant surgery whereby the results can be exported.
DTX Studio Clinic is a computer assisted detection (CADe) device that analyses intraoral radiographs to identify and localize dental findings, which include caries, calculus, periapical radiolucency, root canal filling deficiency, discrepancy at the margin of an existing restoration and bone loss. The DTX Studio Clinic CADe functionality is indicated for use by dentists for the concurrent review of bitewing and periapical radiographs of permanent teeth in patients 15 years of age or older.
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/K231898 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231898: DTX Studio Clinic (4.0).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231898
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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