510(k) · Cleared
ClearedSimplant Immediate Smile Dental Care System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Materialise Dental NV · LLZ System, Image Processing, Radiological
Cleared on May 30, 2012 as substantially equivalent to K110300 (Materialise Dental NV, 2011) and 2 other predicates after a 162-day review. Its family tree reaches back 5 generations to 1993. 3 later devices descend from it.
- Decided
- May 30, 2012
- Review
- 162 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K924630 (1993). 11 ancestors in all, the oldest K924810 (1993). 3 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK924630 Surgicad (TM) View (TM)Surgicad Corp. · 1993
- 4 generations backK970617 CT-Modeller SystemMaterialise NV · 1997
- 3 generations backK033849 Simplant SystemMaterialise NV · 2004
- 2 generations backK053592 Simplant DR. JamesMaterialise NV · 2006
- 1 generation backK110300 Simplant 2011Materialise Dental NV · 2011
- This deviceK113739 Simplant Immediate Smile Dental Care SystemMaterialise Dental NV · 2012
- Descendant · cites it directly · 2 of its ownK170849 SIMPLANT GuideDentsply Sirona · 2017
- Descendant · 2 generations on · 0 of its ownK193405 Simplant Digital GuideDentsply Sirona · 2020
- Descendant · 2 generations on · 0 of its ownK190059 CEREC GuidesDentsply Sirona · 2019
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 |
|---|---|---|---|---|---|
| −5 | K924630 | Surgicad (TM) View (TM) | Surgicad Corp. | 1993 | — |
| −4 | K970617 | CT-Modeller System | Materialise NV | 1997 | — |
| −3 | K033849 | Simplant System | Materialise NV | 2004 | — |
| −2 | K053592 | Simplant DR. James | Materialise NV | 2006 | — |
| −1 | K110300 | Simplant 2011 | Materialise Dental NV | 2011 | — |
| 0 (this device) | K113739 | Simplant Immediate Smile Dental Care System | Materialise Dental NV | 2012 | — |
| +1 | K170849 | SIMPLANT Guide | Dentsply Sirona | 2017 | — |
| +2 | K193405 | Simplant Digital Guide | Dentsply Sirona | 2020 | — |
| +2 | K190059 | CEREC Guides | Dentsply Sirona | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 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 |
|---|---|---|---|
| * | K110300 | Simplant 2011Summary page 2…16 5 10(k) Premarket Notification -SimPlantt Immediate S-mile Systein Predicate Device Simlant® 2011; (K 110300) Manufacturer: Nobel Biocare Guided Surgery Concept; (K050393) _____________Ivoclar Vivadent - Telio… | 2011 |
| * | K050393 | The Guided Surgery ConceptSummary page 2…fication -SimPlantt Immediate S-mile Systein Predicate Device Simlant® 2011; (K 110300) Manufacturer: Nobel Biocare Guided Surgery Concept; (K050393) _____________Ivoclar Vivadent - Telio CAD (K093708) Purpose of the The reason for this 5 10k submis… | 2005 |
| * | K093708 | Telio CadSummary page 2…Simlant® 2011; (K 110300) Manufacturer: Nobel Biocare Guided Surgery Concept; (K050393) _____________Ivoclar Vivadent - Telio CAD (K093708) Purpose of the The reason for this 5 10k submission is to request clearance for a device that has been 510(k) noti… | 2010 |
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 |
|---|---|---|---|
| K170849 | SIMPLANT Guide | 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 19 years and passes through 3 companies; a new generation was cleared every 4.0 years on median.
- 1 of the 11 ancestors has a recall of any class.
- Of its descendants, K170849 (Dentsply Sirona, 2017) has gone furthest, with 2 descendants of its own.
- 8 other devices also cite its predicate K110300.
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?
The Sinilant Immediate Smile System is intended for use in treatment planning and
placement of dental implants, in order to restore masticatory function.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113739 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113739: Simplant Immediate Smile Dental Care System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113739
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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