510(k) · Cleared
ClearedNobelclinician
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 26, 2013 as substantially equivalent to K112251 (Swissmeda AG, 2012) and 2 other predicates after a 90-day review. Its family tree reaches back 7 generations to 1996. 3 later devices descend from it.
- Decided
- Mar 26, 2013
- Review
- 90 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K954678 (1996). 16 ancestors in all, the oldest K924810 (1993). 3 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 backK071636 Codiagnostix (R) 5.72Ivs Solutions AG · 2007 · Recalled
- 1 generation backK112251 Swissmeda Dental Planning SystemSwissmeda AG · 2012
- This deviceK123976 NobelclinicianNobel Biocare AB · 2013
- Descendant · cites it directly · 2 of its ownK163122 NobelClinician, DTX Studio implantNobel Biocare AB · 2017
- Descendant · 2 generations on · 1 of its ownK231898 DTX Studio Clinic (4.0)Nobel Biocare AB · 2023
- Descendant · 3 generations on · 0 of its ownK252086 DTX Studio AssistNobel Biocare C/O Medicim NV · 2025
Most influential descendants
Showing 3 of 3 · See allView 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 | K071636 | Codiagnostix (R) 5.72 | Ivs Solutions AG | 2007 | 2 |
| −1 | K112251 | Swissmeda Dental Planning System | Swissmeda AG | 2012 | — |
| 0 (this device) | K123976 | Nobelclinician | Nobel Biocare AB | 2013 | — |
| +1 | K163122 | NobelClinician, DTX Studio implant | Nobel Biocare AB | 2017 | — |
| +2 | K231898 | DTX Studio Clinic (4.0) | Nobel Biocare AB | 2023 | — |
| +3 | 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 |
|---|---|---|
| 2017 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K112251 | Swissmeda Dental Planning SystemSummary page 1…1 CFR 892.2050) Trade or Proprietary or Model Name: NobelClinician Legally Marketed Device(s): Swissmeda Dental Planning System (K1 12251) The Guided Surgery Concept (K050393) Maxilim (… | 2012 |
| * | K050393 | The Guided Surgery ConceptSummary page 1…NobelClinician Legally Marketed Device(s): Swissmeda Dental Planning System (K1 12251) The Guided Surgery Concept (K050393) Maxilim (1(052424) Device Description: NobelClinician is a software interface for the… | 2005 |
| * | K052424 | MaxilimSummary page 1…smeda Dental Planning System (K1 12251) The Guided Surgery Concept (K050393) Maxilim (1(052424) Device Description: NobelClinician is a software interface for the transfer and visualization of imaging information: 3D imagi… | 2006 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K163122 | NobelClinician, DTX Studio implant | 2017 | 2 |
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 17 years and passes through 6 companies; a new generation was cleared every 2.1 years on median.
- 2 of the 16 ancestors have a recall of any class.
- Of its descendants, K163122 (Nobel Biocare AB, 2017) has gone furthest, with 2 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. 2013, 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?
The NobelClinician software is a software interface for the transfer and visualization of imaging information from equipment such as a CT scanner or a magnetic resonance scanner for the purposes of diagnosis and treatment planning in the dental and cranio-maxillofacial regions. The NobelClinician software can be used to design a surgical template for the purposes of aiding placement of dental implants.
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/K123976 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123976: Nobelclinician.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123976
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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