510(k) · Cleared
ClearedDolphin Imaging
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Patterson Dental Supply, Inc. · LLZ System, Image Processing, Radiological
Cleared on May 11, 2011 after an 86-day review. The FDA summary names its predicate without a number. 9 later devices descend from it.
- Decided
- May 11, 2011
- Review
- 86 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 7 citing it directly.
- This deviceK110430 Dolphin ImagingPatterson Dental Supply, Inc. · 2011
- Descendant · cites it directly · 1 of its ownK190162 SmartCephOrtho2, LLC · 2019
- Descendant · cites it directly · 1 of its ownK131348 OrtomedInfomed Servicios Informaticos S.L. · 2014
- Descendant · 2 generations on · 0 of its ownK241819 CephNinjaCyncronus, LLC · 2025
- Descendant · cites it directly · 0 of its ownK221478 Dolphin Blue ImagingPatterson Dental Supply, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK222072 Dolphin Imaging 12.0Patterson Dental Supply, Inc. · 2022
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K190162SmartCephOrtho2, LLC · 2019 · cites it directly1descendant
- K131348OrtomedInfomed Servicios Informaticos S.L. · 2014 · cites it directly1descendant
- K241819CephNinjaCyncronus, LLC · 2025 · 2 generations on0descendants
- K221478Dolphin Blue ImagingPatterson Dental Supply, Inc. · 2022 · cites it directly0descendants
- K222072Dolphin Imaging 12.0Patterson Dental Supply, Inc. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K110430 | Dolphin Imaging | Patterson Dental Supply, Inc. | 2011 | — |
| +1 | K190162 | SmartCeph | Ortho2, LLC | 2019 | — |
| +1 | K131348 | Ortomed | Infomed Servicios Informaticos S.L. | 2014 | — |
| +2 | K241819 | CephNinja | Cyncronus, LLC | 2025 | — |
| +1 | K221478 | Dolphin Blue Imaging | Patterson Dental Supply, Inc. | 2022 | — |
| +1 | K222072 | Dolphin Imaging 12.0 | Patterson Dental Supply, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2022 | 3 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | — | VistDenat at Complete Named without a submission number | |
| * | — | VitaDent 3D Named without a submission number |
What descends from it? (9)
7 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?
- Of its descendants, K190162 (Ortho2, LLC, 2019) has gone furthest, with 1 descendant of its own.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
Dolphin Imaging software is designed for use by specialized dental practices for capturing, storing and presenting patient images and assisting in treatment planning and case diagnosis. Results produced by the software's diagnostic and treatment planning tools are dependent on the interpretation of trained and licensed practitioners.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110430 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110430: Dolphin Imaging.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110430
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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