510(k) · Cleared
ClearedDS Core CBCT Anatomy
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentsply Sirona · QIH Automated Radiological Image Processing Software
Cleared on Aug 21, 2026 as substantially equivalent to K260785 (Dentsply Sirona, 2026) after a 58-day review. Its family tree reaches back 14 generations to 1996.
- Decided
- Aug 21, 2026
- Review
- 58 days
- Class
- Class II
- Product code
- QIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 14 generations to K954678 (1996). 31 ancestors in all, the oldest K924810 (1993). No later device cites it as a predicate yet.
- Root · 14 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 10 generations between
- 3 generations backK233925 Relu CreatorRelu BV · 2024
- 2 generations backK243989 Second Opinion® 3DPearl, Inc. · 2025
- 1 generation backK260785 DS Core CBCT AnatomyDentsply Sirona · 2026
- This deviceK262127 DS Core CBCT AnatomyDentsply Sirona · 2026
Show all 14 generations
- Root · 14 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 13 generations backK980648 Pro VisionAlgotec Systems, Ltd. · 1998
- 12 generations backK992654 Plug 'N View 3D, Version 1.0Voxar Limited · 1999
- 11 generations backK013878 Cybermed, Inc., V-WorksCybermed, Inc. · 2001
- 10 generations backK053155 VimplantCybermed, Inc. · 2005
- 9 generations backK070803 InvivodentalAnatomage, Inc. · 2007
- 8 generations backK123519 Invivo DentalAnatomage, Inc. · 2013
- 7 generations backK140713 Planmeca RomexisPlanmeca Oy · 2014
- 6 generations backK162799 CliniviewPalodex Group OY · 2017
- 5 generations backK203156 DTX Studio ClinicNobel Biocare AB · 2020
- 4 generations backK213562 DTX Studio Clinic 3.0Nobel Biocare AB · 2022
- 3 generations backK233925 Relu CreatorRelu BV · 2024
- 2 generations backK243989 Second Opinion® 3DPearl, Inc. · 2025
- 1 generation backK260785 DS Core CBCT AnatomyDentsply Sirona · 2026
- This deviceK262127 DS Core CBCT AnatomyDentsply Sirona · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K954678 | Pro Vision | Algotec Systems, Ltd. | 1996 | — |
| −13 | K980648 | Pro Vision | Algotec Systems, Ltd. | 1998 | — |
| −12 | K992654 | Plug 'N View 3D, Version 1.0 | Voxar Limited | 1999 | — |
| −11 | K013878 | Cybermed, Inc., V-Works | Cybermed, Inc. | 2001 | — |
| −10 | K053155 | Vimplant | Cybermed, Inc. | 2005 | — |
| −9 | K070803 | Invivodental | Anatomage, Inc. | 2007 | — |
| −8 | K123519 | Invivo Dental | Anatomage, Inc. | 2013 | — |
| −7 | K140713 | Planmeca Romexis | Planmeca Oy | 2014 | — |
| −6 | K162799 | Cliniview | Palodex Group OY | 2017 | — |
| −5 | K203156 | DTX Studio Clinic | Nobel Biocare AB | 2020 | — |
| −4 | K213562 | DTX Studio Clinic 3.0 | Nobel Biocare AB | 2022 | — |
| −3 | K233925 | Relu Creator | Relu BV | 2024 | — |
| −2 | K243989 | Second Opinion® 3D | Pearl, Inc. | 2025 | — |
| −1 | K260785 | DS Core CBCT Anatomy | Dentsply Sirona | 2026 | — |
| 0 (this device) | K262127 | DS Core CBCT Anatomy | Dentsply Sirona | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 3 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 4 | 0 |
| 2008 | 1 | 0 |
| 2014 | 2 | 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 QIH? 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 QIH device
- #1 K213998 cvi42 Auto Imaging Software Applicationscore 23.5 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K260785 | DS Core CBCT AnatomySummary page 5…21 CFR 807.92(a)(3) Predicate# Predicate Trade Name (Primary Predicate is listed first) Product Code I K260785 11 DS Core CBCT Anatomy… | 2026 |
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 30 years and passes through 10 companies; a new generation was cleared every 2.1 years on median.
- 2 of the 31 ancestors have a recall of any class.
How does its category compare?
All QIH devicesQIH Automated Radiological Image Processing Software: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · QIH
94in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QIH
150in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QIH
1so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QIH
4in 2025
MAUDE reports naming product code QIH, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 11 | 145 | 0 | 0 |
| 2021 | 19 | 125 | 0 | 0 |
| 2022 | 25 | 134 | 0 | 0 |
| 2023 | 45 | 151 | 0 | 0 |
| 2024 | 64 | 141 | 0 | 2 |
| 2025 | 94 | 150 | 0 | 4 |
| 2026 | 78 | 130 | 1 | — |
What is it indicated for?
“DS Core CBCT Anatomy” is a cloud-based Al/ML enabled software as a medical device. The device is available as a back end service via an API (Application Programming Interface). The device is intended to be used by dental professionals when reviewing Digital Impression (DI) scans and CBCT (DX) scans during standard of care diagnostic review and treatment planning. DS Core CBCT Anatomy analyses CBCT scans and Digital Impression (DI) scans to identify…
Read the full statement (123 words)
“DS Core CBCT Anatomy” is a cloud-based Al/ML enabled software as a medical device. The device is available as a back end service via an API (Application Programming Interface). The device is intended to be used by dental professionals when reviewing Digital Impression (DI) scans and CBCT (DX) scans during standard of care diagnostic review and treatment planning. DS Core CBCT Anatomy analyses CBCT scans and Digital Impression (DI) scans to identify anatomical structures, propose a panoramic curve, segmentation of teeth, jaws, and the inferior alveolar nerve canal (IAN), as well as to perform image registration to support the review of CBCT dental images and DI scans.
This device is intended to be used with patients aged 12 and older with permanent dentition.
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/K262127 · printed Nov 6, 2026
Cite this page
510(k) Report. “K262127: DS Core CBCT Anatomy.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K262127
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026