510(k) · Cleared
ClearedDentiqAir
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3D Industrial Imaging Co., Ltd. · LLZ System, Image Processing, Radiological
Cleared on Dec 19, 2019 as substantially equivalent to K110430 (Patterson Dental Supply, Inc., 2011) and 1 other predicate after a 356-day review. Its family tree reaches back 7 generations to 1993.
- Decided
- Dec 19, 2019
- Review
- 356 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K924630 (1993). 11 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 backK081402 Simplant Ortho ; Vistadent 3DMaterialise Dental NV · 2008
- 2 generations backK103723 Sicat Implant V1.2Sicat GmbH & Co. KG · 2011
- 1 generation backK133320 Sicat FunctionSicat GmbH & Co. KG · 2014
- This deviceK183676 DentiqAir3D Industrial Imaging Co., Ltd. · 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 | K081402 | Simplant Ortho ; Vistadent 3D | Materialise Dental NV | 2008 | — |
| −2 | K103723 | Sicat Implant V1.2 | Sicat GmbH & Co. KG | 2011 | — |
| −1 | K133320 | Sicat Function | Sicat GmbH & Co. KG | 2014 | — |
| 0 (this device) | K183676 | DentiqAir | 3D Industrial Imaging Co., Ltd. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 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? (2)
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 |
|---|---|---|---|
| * | K110430 | Dolphin ImagingSummary page 5…be exported from DentiqAir and used as input data for CAD or Rapid Prototyping Systems. 05. Predicate Device Identification - Reference predicate device 510(k) Number: K110430 Device Name: Dolphin Imaging Manufacturer: PATTERSON DENTAL SUPPLY, INC - Primary predicate device 510(k) Number: K133320 Device… | 2011 |
| * | K133320 | Sicat FunctionSummary page 5…on - Reference predicate device 510(k) Number: K110430 Device Name: Dolphin Imaging Manufacturer: PATTERSON DENTAL SUPPLY, INC - Primary predicate device 510(k) Number: K133320 Device Name: SICAT Function Manufacturer: SICAT GmbH & Co, KG 06. Device Description DentiqAir is a pure software device applied… | 2014 |
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 5 companies; a new generation was cleared every 2.8 years on median.
- None of the 11 ancestors has a recall.
- 6 other devices also cite its predicate K110430.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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?
DentiqAir is a software application for the visualization and segmentation of imaging information of the oral-maxillofacial region.
The imaging data originates from medical scanners such as CT or CBCT scanners.
The dental professionals' planning data may be exported from DentiqAir and used as input data for CAD or Rapid Prototyping Systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K183676 · printed Nov 4, 2026
Cite this page
510(k) Report. “K183676: DentiqAir.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K183676
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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