510(k) · Cleared
ClearedImplanter Dental Planning Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Implanter, LLC · LLZ System, Image Processing, Radiological
Cleared on Dec 3, 2018 as substantially equivalent to K060267 (Implant Logic Systems, Ltd., 2006) and 1 other predicate after a 430-day review. Its family tree reaches back 6 generations to 1993.
- Decided
- Dec 3, 2018
- Review
- 430 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K924630 (1993). 9 ancestors in all, the oldest K924810 (1993). No later device cites it as a predicate yet.
- Root · 6 generations backK924630 Surgicad (TM) View (TM)Surgicad Corp. · 1993
- 5 generations backK970617 CT-Modeller SystemMaterialise NV · 1997
- 4 generations backK033849 Simplant SystemMaterialise NV · 2004
- 3 generations backK061472 Galileos Implant, V 1.0Sicat GmbH & Co. KG · 2006
- 2 generations backK090119 Sicat ImplantSicat GmbH & Co. KG · 2009
- 1 generation backK113404 Dental 3D Planning SoftwareSymbyo Dental, LLC · 2011
- This deviceK173083 Implanter Dental Planning SoftwareImplanter, LLC · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K924630 | Surgicad (TM) View (TM) | Surgicad Corp. | 1993 | — |
| −5 | K970617 | CT-Modeller System | Materialise NV | 1997 | — |
| −4 | K033849 | Simplant System | Materialise NV | 2004 | — |
| −3 | K061472 | Galileos Implant, V 1.0 | Sicat GmbH & Co. KG | 2006 | — |
| −2 | K090119 | Sicat Implant | Sicat GmbH & Co. KG | 2009 | — |
| −1 | K113404 | Dental 3D Planning Software | Symbyo Dental, LLC | 2011 | — |
| 0 (this device) | K173083 | Implanter Dental Planning Software | Implanter, LLC | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 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? (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 |
|---|---|---|---|
| * | K060267 | Virtual Implant Placement (Vip) Dental Implant Surgery Planning SoftwareSummary page 5…PLANTER DENTAL PLANNING SOFTWARE is equivalent to the VIRTUAL IMPLANT PLACEMENT (VIP) DENTAL IMPLANT SURGERY PLANNING SOFTWARE by Implant Logic Systems Ltd cleared under K060267 and the IPS software by Symbio Dental LLC cleared under K113404. Technical Characteristics Comparison: The basic and main techni… | 2006 |
| * | K113404 | Dental 3D Planning SoftwareSummary page 5…PLANT PLACEMENT (VIP) DENTAL IMPLANT SURGERY PLANNING SOFTWARE by Implant Logic Systems Ltd cleared under K060267 and the IPS software by Symbio Dental LLC cleared under K113404. Technical Characteristics Comparison: The basic and main technical features of the subject device IMPLANTER DENTAL PLANNING SOF… | 2011 |
| † | K050258 | Groovy Implants | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
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 25 years and passes through 5 companies; a new generation was cleared every 4.0 years on median.
- None of the 9 ancestors has a recall.
- 2 other devices also cite its predicate K060267.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 IMPLANTER DENTAL PLANNING SOFTWARE is a device that employs previously scanned DICOM CT images in a software tool which serves as an aid to visualizing and preplanning of dental implant surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173083 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173083: Implanter Dental Planning Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173083
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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