510(k) · Cleared
ClearedSwissmeda Dental Planning System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Swissmeda AG · LLZ System, Image Processing, Radiological
Cleared on Jan 25, 2012 as substantially equivalent to K071636 (Ivs Solutions AG, 2007) after a 173-day review. Its family tree reaches back 6 generations to 1996. 4 later devices descend from it.
- Decided
- Jan 25, 2012
- Review
- 173 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K954678 (1996). 10 ancestors in all, the oldest K924810 (1993). 4 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 5 generations backK980648 Pro VisionAlgotec Systems, Ltd. · 1998
- 4 generations backK992654 Plug 'N View 3D, Version 1.0Voxar Limited · 1999
- 3 generations backK013878 Cybermed, Inc., V-WorksCybermed, Inc. · 2001
- 2 generations backK053155 VimplantCybermed, Inc. · 2005
- 1 generation backK071636 Codiagnostix (R) 5.72Ivs Solutions AG · 2007 · Recalled
- This deviceK112251 Swissmeda Dental Planning SystemSwissmeda AG · 2012
- Descendant · cites it directly · 3 of its ownK123976 NobelclinicianNobel Biocare AB · 2013
- Descendant · 2 generations on · 2 of its ownK163122 NobelClinician, DTX Studio implantNobel Biocare AB · 2017
- Descendant · 3 generations on · 1 of its ownK231898 DTX Studio Clinic (4.0)Nobel Biocare AB · 2023
- Descendant · 4 generations on · 0 of its ownK252086 DTX Studio AssistNobel Biocare C/O Medicim NV · 2025
Most influential descendants
Showing 4 of 4 · See all- K123976NobelclinicianNobel Biocare AB · 2013 · cites it directly3descendants
- K163122NobelClinician, DTX Studio implantNobel Biocare AB · 2017 · 2 generations on2descendants
- K231898DTX Studio Clinic (4.0)Nobel Biocare AB · 2023 · 3 generations on1descendant
- K252086DTX Studio AssistNobel Biocare C/O Medicim NV · 2025 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K954678 | Pro Vision | Algotec Systems, Ltd. | 1996 | — |
| −5 | K980648 | Pro Vision | Algotec Systems, Ltd. | 1998 | — |
| −4 | K992654 | Plug 'N View 3D, Version 1.0 | Voxar Limited | 1999 | — |
| −3 | K013878 | Cybermed, Inc., V-Works | Cybermed, Inc. | 2001 | — |
| −2 | K053155 | Vimplant | Cybermed, Inc. | 2005 | — |
| −1 | K071636 | Codiagnostix (R) 5.72 | Ivs Solutions AG | 2007 | 2 |
| 0 (this device) | K112251 | Swissmeda Dental Planning System | Swissmeda AG | 2012 | — |
| +1 | K123976 | Nobelclinician | Nobel Biocare AB | 2013 | — |
| +2 | K163122 | NobelClinician, DTX Studio implant | Nobel Biocare AB | 2017 | — |
| +3 | K231898 | DTX Studio Clinic (4.0) | Nobel Biocare AB | 2023 | — |
| +4 | 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 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K071636 | Codiagnostix (R) 5.72Summary page 1…cate Device Manufacturer: IVS Solutions AG, Annaberger Strasse 240, Chemnitz, Germany Trade Name: coDiagnostiX® 510(k) Number: K071 636 Regulation Number: 892.2050 Product Code: LLZ Swissmeda AG… | 2007 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123976 | Nobelclinician | 2013 | 3 |
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 16 years and passes through 5 companies; a new generation was cleared every 2.5 years on median.
- 1 of the 10 ancestors has a recall of any class.
- Of its descendants, K123976 (Nobel Biocare AB, 2013) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K071636.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?
Swissmeda Dental Planning System is intended for use by qualified dental professionals for WindowsO based diagnostics and implant planning. The software is an interface for imaging data that originates from medical scanners such as ar or DVT scanners and it is also a pre-operative software for simulation and evaluation of dental implant placement in the patient's mandible/maxilla and for surgical treatment options. Swissmeda Implant Planning System is…
Read the full statement (138 words)
Swissmeda Dental Planning System is intended for use by qualified dental professionals for WindowsO based diagnostics and implant planning. The software is an interface for imaging data that originates from medical scanners such as ar or DVT scanners and it is also a pre-operative software for simulation and evaluation of dental implant placement in the patient's mandible/maxilla and for surgical treatment options.
Swissmeda Implant Planning System is not intended to be used in direct contact with the patient nor is it intended to be used with life sustaining devices.
The planning data may be exported from Swissmeda Dental Planning System and used as input data for a special drilling device from company Georg Schick for manufacturing drilling templates in a laboratory environment. The drilling template isthen used in direct contact with the patient to realize the implant planning.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112251 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112251: Swissmeda Dental Planning System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112251
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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