510(k) · Cleared
ClearedImplantmaster
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
I-Dent · LLZ System, Image Processing, Radiological
Cleared on Oct 21, 2004 as substantially equivalent to K033849 (Materialise NV, 2004) after a 66-day review. Its family tree reaches back 3 generations to 1993. 44 later devices descend from it.
- Decided
- Oct 21, 2004
- Review
- 66 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K924630 (1993). 4 ancestors in all, the oldest K924810 (1993). 44 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK924630 Surgicad (TM) View (TM)Surgicad Corp. · 1993
- 2 generations backK970617 CT-Modeller SystemMaterialise NV · 1997
- 1 generation backK033849 Simplant SystemMaterialise NV · 2004
- This deviceK042212 ImplantmasterI-Dent · 2004
- Descendant · cites it directly · 43 of its ownK060267 Virtual Implant Placement (Vip) Dental Implant Surgery Planning…Implant Logic Systems, Ltd. · 2006
- Descendant · 2 generations on · 38 of its ownK070803 InvivodentalAnatomage, Inc. · 2007
- Descendant · 3 generations on · 24 of its ownK123519 Invivo DentalAnatomage, Inc. · 2013
- Descendant · 4 generations on · 14 of its ownK140713 Planmeca RomexisPlanmeca Oy · 2014
- Descendant · 5 generations on · 13 of its ownK162799 CliniviewPalodex Group OY · 2017
Showing 5 of 44 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 44 · See all- K060267Virtual Implant Placement (Vip) Dental Implant Surgery Planning SoftwareImplant Logic Systems, Ltd. · 2006 · cites it directly43descendants
- K070803InvivodentalAnatomage, Inc. · 2007 · 2 generations on38descendants
- K123519Invivo DentalAnatomage, Inc. · 2013 · 3 generations on24descendants
- K140713Planmeca RomexisPlanmeca Oy · 2014 · 4 generations on14descendants
- K162799CliniviewPalodex Group OY · 2017 · 5 generations on13descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K924630 | Surgicad (TM) View (TM) | Surgicad Corp. | 1993 | — |
| −2 | K970617 | CT-Modeller System | Materialise NV | 1997 | — |
| −1 | K033849 | Simplant System | Materialise NV | 2004 | — |
| 0 (this device) | K042212 | Implantmaster | I-Dent | 2004 | — |
| +1 | K060267 | Virtual Implant Placement (Vip) Dental Implant Surgery Planning Software | Implant Logic Systems, Ltd. | 2006 | — |
| +2 | K070803 | Invivodental | Anatomage, Inc. | 2007 | — |
| +3 | K123519 | Invivo Dental | Anatomage, Inc. | 2013 | — |
| +4 | K140713 | Planmeca Romexis | Planmeca Oy | 2014 | — |
| +5 | K162799 | Cliniview | Palodex Group OY | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 4 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2016 | 4 | 0 |
| 2017 | 3 | 0 |
| 2018 | 5 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 4 | 0 |
| 2026 | 6 | 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 |
|---|---|---|---|
| * | K033849 | Simplant System Our reading of the summary gave K033847, FDA’s number for A1CNOW for Home and Professional Use (Metrika, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “SimPlant system”. | 2004 |
What descends from it? (44)
See all 441 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K060267 | Virtual Implant Placement (Vip) Dental Implant Surgery Planning Software | 2006 | 43 |
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 11 years and passes through 3 companies; a new generation was cleared every 4.0 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K060267 (Implant Logic Systems, Ltd., 2006) has gone furthest, with 43 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 ImplantMaster system is indicated for use as a front-end software interface for the transfer of imaging information from a medical scanner such as a CT scanner. It is also indicated for use as a planning and simulation software for use by qualified dental professionals to aid them in the placement of dental implants and surgical treatment.
ImplantMaster processes the dental professional's input information and the result is used as an input data for CAD or Rapid Prototyping System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042212 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042212: Implantmaster.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042212
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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