510(k) · Cleared
ClearedCEREC Guides
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 27, 2019 as substantially equivalent to K170849 (Dentsply Sirona, 2017) after a 259-day review. Its family tree reaches back 7 generations to 1993.
- Decided
- Sep 27, 2019
- Review
- 259 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 deviceK190059 CEREC GuidesDentsply Sirona · 2019
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) | 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 |
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 |
|---|---|---|---|
| * | K170849 | SIMPLANT GuideSummary page 4…510(k) Company Name Clearance SIMPLANT Guide K170849 Dentsply Sirona Traditional 510(k): CEREC Guides 510(k) Summary Page 1 of 7 Dents… | 2017 |
| † | K181520 | Sirona Dental CAD/CAM System | 2018 |
| † | K093090 | Galileos Implant, Version 1.7 | 2009 |
| † | K073173 | Self-Adhesive Resin Cement | 2008 |
| † | K071548 | Wieland Zeno Cao Temporary Pmma Disc, Tooth-Colored | 2007 |
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 26 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. 2019, 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?
CEREC Guides are intended to support the dentist or oral surgeon when drilling for placement of dental implants. CEREC Guides are intended to be designed and fabricated using the Sirona Dental CAD/CAM System’s CEREC Chairside software and CAM equipment, Galileos Implant dental implant planning software, and Calibra Universal Self-Adhesive Resin Cement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190059 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190059: CEREC Guides.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190059
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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