510(k) · Cleared
ClearedSIMPLANT Guide
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentsply Sirona · NDP Accessories, Implant, Dental, Endosseous
Cleared on Jun 15, 2017 as substantially equivalent to K113739 (Materialise Dental NV, 2012) after an 85-day review. Its family tree reaches back 6 generations to 1993. 2 later devices descend from it.
- Decided
- Jun 15, 2017
- Review
- 85 days
- Class
- Class I
- Product code
- NDP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K924630 (1993). 12 ancestors in all, the oldest K924810 (1993). 2 later devices descend from it, 2 citing it directly.
- 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 backK053592 Simplant DR. JamesMaterialise NV · 2006
- 2 generations backK110300 Simplant 2011Materialise Dental NV · 2011
- 1 generation backK113739 Simplant Immediate Smile Dental Care SystemMaterialise Dental NV · 2012
- This deviceK170849 SIMPLANT GuideDentsply Sirona · 2017
- Descendant · cites it directly · 0 of its ownK193405 Simplant Digital GuideDentsply Sirona · 2020
- Descendant · cites it directly · 0 of its ownK190059 CEREC GuidesDentsply Sirona · 2019
Most influential descendants
Showing 2 of 2 · See allView 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 | K053592 | Simplant DR. James | Materialise NV | 2006 | — |
| −2 | K110300 | Simplant 2011 | Materialise Dental NV | 2011 | — |
| −1 | K113739 | Simplant Immediate Smile Dental Care System | Materialise Dental NV | 2012 | — |
| 0 (this device) | K170849 | SIMPLANT Guide | Dentsply Sirona | 2017 | — |
| +1 | K193405 | Simplant Digital Guide | Dentsply Sirona | 2020 | — |
| +1 | 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 |
|---|---|---|
| 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 NDP? 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 NDP device
- #1 K193405 Simplant Digital Guidescore 1.7 · 7 generations · no Class I recall
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 |
|---|---|---|---|
| * | K113739 | Simplant Immediate Smile Dental Care SystemSummary page 4…NDP Predicate Device: Predicate Device Names 510(k) Manufacturer SimPlant® Immediate Smile System K113739 DENTSPLY Implants NV (Primary Predicate) Frialit-2 Select Components K993095 Dentsply Imp… | 2012 |
| † | K993095 | Frialit-2 Select Components | 1999 |
| † | K993560 | Frialit-2 Bone Profiler | 2000 |
What descends from it? (2)
2 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 24 years and passes through 4 companies; a new generation was cleared every 5.0 years on median.
- 1 of the 12 ancestors has a recall of any class.
- Of its descendants, K193405 (Dentsply Sirona, 2020) has gone furthest, with 0 descendants of its own.
How does its category compare?
All NDP devicesNDP Accessories, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · NDP
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · NDP
Too few NDP 510(k)s in any year since 2007 to give a median.
Recalls per year · NDP
6in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NDP
389in 2025
MAUDE reports naming product code NDP, 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 | 1 | — | 0 | 1 |
| 2008 | 0 | — | 1 | 2 |
| 2009 | 0 | — | 1 | 0 |
| 2010 | 0 | — | 1 | 12 |
| 2011 | 0 | — | 0 | 25 |
| 2012 | 0 | — | 1 | 10 |
| 2013 | 0 | — | 1 | 2 |
| 2014 | 0 | — | 1 | 41 |
| 2015 | 0 | — | 5 | 103 |
| 2016 | 0 | — | 2 | 96 |
| 2017 | 1 | — | 5 | 240 |
| 2018 | 0 | — | 4 | 278 |
| 2019 | 1 | — | 0 | 262 |
| 2020 | 1 | — | 0 | 183 |
| 2021 | 0 | — | 6 | 237 |
| 2022 | 0 | — | 0 | 188 |
| 2023 | 0 | — | 0 | 212 |
| 2024 | 0 | — | 0 | 224 |
| 2025 | 0 | — | 0 | 389 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The SIMPLANT® Guide is intended for use in assisting placement of dental implants.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K170849 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170849: SIMPLANT Guide.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170849
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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