510(k) · Cleared
ClearedNobelClinician, DTX Studio implant
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 Jan 31, 2017 as substantially equivalent to K123976 (Nobel Biocare AB, 2013) after an 84-day review. Its family tree reaches back 8 generations to 1996. 2 later devices descend from it.
- Decided
- Jan 31, 2017
- Review
- 84 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K954678 (1996). 17 ancestors in all, the oldest K924810 (1993). 2 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 7 generations backK980648 Pro VisionAlgotec Systems, Ltd. · 1998
- 6 generations backK992654 Plug 'N View 3D, Version 1.0Voxar Limited · 1999
- 5 generations backK013878 Cybermed, Inc., V-WorksCybermed, Inc. · 2001
- 4 generations backK053155 VimplantCybermed, Inc. · 2005
- 3 generations backK071636 Codiagnostix (R) 5.72Ivs Solutions AG · 2007 · Recalled
- 2 generations backK112251 Swissmeda Dental Planning SystemSwissmeda AG · 2012
- 1 generation backK123976 NobelclinicianNobel Biocare AB · 2013
- This deviceK163122 NobelClinician, DTX Studio implantNobel Biocare AB · 2017
- Descendant · cites it directly · 1 of its ownK231898 DTX Studio Clinic (4.0)Nobel Biocare AB · 2023
- Descendant · 2 generations on · 0 of its ownK252086 DTX Studio AssistNobel Biocare C/O Medicim NV · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K954678 | Pro Vision | Algotec Systems, Ltd. | 1996 | — |
| −7 | K980648 | Pro Vision | Algotec Systems, Ltd. | 1998 | — |
| −6 | K992654 | Plug 'N View 3D, Version 1.0 | Voxar Limited | 1999 | — |
| −5 | K013878 | Cybermed, Inc., V-Works | Cybermed, Inc. | 2001 | — |
| −4 | K053155 | Vimplant | Cybermed, Inc. | 2005 | — |
| −3 | K071636 | Codiagnostix (R) 5.72 | Ivs Solutions AG | 2007 | 2 |
| −2 | K112251 | Swissmeda Dental Planning System | Swissmeda AG | 2012 | — |
| −1 | K123976 | Nobelclinician | Nobel Biocare AB | 2013 | — |
| 0 (this device) | K163122 | NobelClinician, DTX Studio implant | Nobel Biocare AB | 2017 | — |
| +1 | K231898 | DTX Studio Clinic (4.0) | Nobel Biocare AB | 2023 | — |
| +2 | 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 | 2 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K123976 | NobelclinicianSummary page 4…LLZ Device Classification 2 III. Predicate Device Substantial equivalence is claimed to the following device: NobelClinician®, K123976, Nobel Biocare AB K163122: Interactive-01 (19 DEC 2016)… | 2013 |
| † | K152078 | Implant Studio 2015 | 2015 |
| † | K130724 | Codiagnostix Implant Planning Software | 2013 |
| † | K110300 | Simplant 2011 | 2011 |
| † | K112251 | Swissmeda Dental Planning System | 2012 |
| † | K123519 | Invivo Dental | 2013 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K231898 | DTX Studio Clinic (4.0) | 2023 | 1 |
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 21 years and passes through 6 companies; a new generation was cleared every 2.5 years on median.
- 2 of the 17 ancestors have a recall of any class.
- Of its descendants, K231898 (Nobel Biocare AB, 2023) has gone furthest, with 1 descendant 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. 2017, 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?
NobelClinician® (DTX Studio Implant) is a software interface for the transfer and visualization of 2D and 3D image information from equipment such as a CT scanner for the purposes of supporting the diagnostic process, treatment planning and follow-up in the dental and cranio-maxillofacial regions,
NobelClinician® (DTX Studio Implant) can be used to support guided implant surgery and to provide design input for and review of dental restorative solutions, The results can be exported to be manufactured.
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/K163122 · printed Nov 5, 2026
Cite this page
510(k) Report. “K163122: NobelClinician, DTX Studio implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K163122
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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