510(k) · Cleared
ClearedVimplant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cybermed, Inc. · LLZ System, Image Processing, Radiological
Cleared on Nov 23, 2005 as substantially equivalent to K033849 (Materialise NV, 2004) and 1 other predicate after a 9-day review. Its family tree reaches back 4 generations to 1996. 63 later devices descend from it.
- Decided
- Nov 23, 2005
- Review
- 9 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K954678 (1996). 8 ancestors in all, the oldest K924810 (1993). 63 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 3 generations backK980648 Pro VisionAlgotec Systems, Ltd. · 1998
- 2 generations backK992654 Plug 'N View 3D, Version 1.0Voxar Limited · 1999
- 1 generation backK013878 Cybermed, Inc., V-WorksCybermed, Inc. · 2001
- This deviceK053155 VimplantCybermed, Inc. · 2005
- Descendant · cites it directly · 38 of its ownK070803 InvivodentalAnatomage, Inc. · 2007
- Descendant · 2 generations on · 24 of its ownK123519 Invivo DentalAnatomage, Inc. · 2013
- Descendant · cites it directly · 21 of its ownK071636 Codiagnostix (R) 5.72Ivs Solutions AG · 2007 · Recalled
- Descendant · 2 generations on · 15 of its ownK130724 Codiagnostix Implant Planning SoftwareStraumann USA · 2013
- Descendant · 3 generations on · 14 of its ownK140713 Planmeca RomexisPlanmeca Oy · 2014
Showing 5 of 63 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 63 · See all- K070803InvivodentalAnatomage, Inc. · 2007 · cites it directly38descendants
- K123519Invivo DentalAnatomage, Inc. · 2013 · 2 generations on24descendants
- K071636Codiagnostix (R) 5.72Ivs Solutions AG · 2007 · cites it directly21descendants
- K130724Codiagnostix Implant Planning SoftwareStraumann USA · 2013 · 2 generations on15descendants
- K140713Planmeca RomexisPlanmeca Oy · 2014 · 3 generations on14descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K954678 | Pro Vision | Algotec Systems, Ltd. | 1996 | — |
| −3 | K980648 | Pro Vision | Algotec Systems, Ltd. | 1998 | — |
| −2 | K992654 | Plug 'N View 3D, Version 1.0 | Voxar Limited | 1999 | — |
| −1 | K013878 | Cybermed, Inc., V-Works | Cybermed, Inc. | 2001 | — |
| 0 (this device) | K053155 | Vimplant | Cybermed, Inc. | 2005 | — |
| +1 | K070803 | Invivodental | Anatomage, Inc. | 2007 | — |
| +2 | K123519 | Invivo Dental | Anatomage, Inc. | 2013 | — |
| +1 | K071636 | Codiagnostix (R) 5.72 | Ivs Solutions AG | 2007 | 2 |
| +2 | K130724 | Codiagnostix Implant Planning Software | Straumann USA | 2013 | — |
| +3 | K140713 | Planmeca Romexis | Planmeca Oy | 2014 | — |
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 |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 6 | 0 |
| 2014 | 4 | 0 |
| 2015 | 2 | 0 |
| 2016 | 5 | 0 |
| 2017 | 4 | 0 |
| 2018 | 6 | 0 |
| 2019 | 3 | 0 |
| 2020 | 5 | 0 |
| 2021 | 4 | 0 |
| 2022 | 2 | 0 |
| 2023 | 3 | 0 |
| 2024 | 2 | 0 |
| 2025 | 4 | 0 |
| 2026 | 7 | 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? (2)
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 |
|---|---|---|---|
| * | K033849 | Simplant SystemSummary page 1…s system 3. Predicate Devices : Manufacturer :MATERIALISE N.V. Device :SimPlant System 510(k) Number :K033849 (Decision Date - 05/25/2004) Manufacturer: CyberMed, Inc. Device: V-workSTM… | 2004 |
| * | K013878 | Cybermed, Inc., V-WorksSummary page 1…:K033849 (Decision Date - 05/25/2004) Manufacturer: CyberMed, Inc. Device: V-workSTM 510(k) Number: K01 3878 (Decision Date - 12/07/2001) 4. Classifications Names & Citations: 21CFR 820.2050, LLZ, Picture archiving and communicati… | 2001 |
What descends from it? (63)
See all 633 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 9 years and passes through 3 companies; a new generation was cleared every 2.5 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K070803 (Anatomage, Inc., 2007) has gone furthest, with 38 descendants of its own.
- 19 other devices also cite its predicate K033849.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Vimplant is intended for use as a software interface for the transfer of imaging information from a CT scanner and also as a pre-operative software for simulation and evaluation dental implant placement and surgical treatment options.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053155 · printed Nov 4, 2026
Cite this page
510(k) Report. “K053155: Vimplant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K053155
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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