510(k) · Cleared
ClearedSimplant Digital 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 Sep 2, 2020 as substantially equivalent to K170849 (Dentsply Sirona, 2017) after a 268-day review. Its family tree reaches back 7 generations to 1993.
- Decided
- Sep 2, 2020
- Review
- 268 days
- Class
- Class I
- Product code
- NDP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K924630 (1993). 13 ancestors in all, the oldest K924810 (1993). No later device cites it as a predicate yet.
- Root · 7 generations backK924630 Surgicad (TM) View (TM)Surgicad Corp. · 1993
- 6 generations backK970617 CT-Modeller SystemMaterialise NV · 1997
- 5 generations backK033849 Simplant SystemMaterialise NV · 2004
- 4 generations backK053592 Simplant DR. JamesMaterialise NV · 2006
- 3 generations backK110300 Simplant 2011Materialise Dental NV · 2011
- 2 generations backK113739 Simplant Immediate Smile Dental Care SystemMaterialise Dental NV · 2012
- 1 generation backK170849 SIMPLANT GuideDentsply Sirona · 2017
- This deviceK193405 Simplant Digital GuideDentsply Sirona · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K924630 | Surgicad (TM) View (TM) | Surgicad Corp. | 1993 | — |
| −6 | K970617 | CT-Modeller System | Materialise NV | 1997 | — |
| −5 | K033849 | Simplant System | Materialise NV | 2004 | — |
| −4 | K053592 | Simplant DR. James | Materialise NV | 2006 | — |
| −3 | K110300 | Simplant 2011 | Materialise Dental NV | 2011 | — |
| −2 | K113739 | Simplant Immediate Smile Dental Care System | Materialise Dental NV | 2012 | — |
| −1 | K170849 | SIMPLANT Guide | Dentsply Sirona | 2017 | — |
| 0 (this device) | K193405 | Simplant Digital Guide | Dentsply Sirona | 2020 | — |
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 |
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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K170849 | SIMPLANT GuideSummary page 4…Predicate Device 510(k) Company Name Name Simplant® Guide K170849 Dentsply Sirona Description of Device: The Simplant® Digital Guide is intended for use i… | 2017 |
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 27 years and passes through 4 companies; a new generation was cleared every 4.0 years on median.
- 1 of the 13 ancestors has a recall of any class.
- 1 other device also cites its predicate K170849.
How does its category compare?
All NDP devicesNDP Accessories, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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® Digital Guide is a surgical guide intended for use in assisting in the placement of dental implants. The Simplant® Digital Guide is designed centrally by the Simplant® planning software and manufactured locally using Formlabs Dental SG resin, Loctite 4304 adhesive, and Formlabs equipment: Form 2 printer, FormWash and FormCure washing and post-curing equipment.
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/K193405 · printed Nov 4, 2026
Cite this page
510(k) Report. “K193405: Simplant Digital Guide.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K193405
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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