510(k) · Cleared
ClearedOverjet Dental Assist
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Overjet, Inc. · LLZ System, Image Processing, Radiological
Cleared on May 19, 2021 as substantially equivalent to K192888 (Ewoosoft Co., Ltd., 2020) after a 114-day review. Its family tree reaches back 8 generations to 1993. 6 later devices descend from it.
- Decided
- May 19, 2021
- Review
- 114 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K930527 (1993). 9 ancestors in all. 6 later devices descend from it, 5 citing it directly.
- Root · 8 generations backK930527 Dental LinkEscan, Inc. · 1993
- 7 generations backK955237 Tigerscan/TigerviewTau Corp. · 1996
- 6 generations backK012439 Dentaleye 2 Dental Image Management SystemRadco Data AB · 2002
- 5 generations backK043104 Kodak Orthodontic Imaging and Oms Imaging 8.0Practiceworks, Inc. · 2005
- 4 generations backK122427 CS Orthodontic Imaging Software CS Oms Imaging SoftwareCarestream Dental, LLC · 2012
- 3 generations backK131570 OrthovisionEwoosoft Co., Ltd. · 2013
- 2 generations backK173094 OrthoVisionEwoosoft Co., Ltd. · 2017
- 1 generation backK192888 EzOrthoEwoosoft Co., Ltd. · 2020
- This deviceK210187 Overjet Dental AssistOverjet, Inc. · 2021
- Descendant · cites it directly · 1 of its ownK230144 Denti.AI DetectDenti.Ai Technology, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK260851 Better Diagnostics Dental Assist (BDDA) Version 1.0Better Diagnostics AI Corp. · 2026
- Descendant · 2 generations on · 0 of its ownK250525 Second Opinion® PanoramicPearl, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK243230 Second Opinion® BLEPearl, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK232440 Adravision PerioAdra Corporation · 2023
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K230144Denti.AI DetectDenti.Ai Technology, Inc. · 2023 · cites it directly1descendant
- K260851Better Diagnostics Dental Assist (BDDA) Version 1.0Better Diagnostics AI Corp. · 2026 · cites it directly0descendants
- K250525Second Opinion® PanoramicPearl, Inc. · 2025 · 2 generations on0descendants
- K243230Second Opinion® BLEPearl, Inc. · 2025 · cites it directly0descendants
- K232440Adravision PerioAdra Corporation · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K930527 | Dental Link | Escan, Inc. | 1993 | — |
| −7 | K955237 | Tigerscan/Tigerview | Tau Corp. | 1996 | — |
| −6 | K012439 | Dentaleye 2 Dental Image Management System | Radco Data AB | 2002 | — |
| −5 | K043104 | Kodak Orthodontic Imaging and Oms Imaging 8.0 | Practiceworks, Inc. | 2005 | — |
| −4 | K122427 | CS Orthodontic Imaging Software CS Oms Imaging Software | Carestream Dental, LLC | 2012 | — |
| −3 | K131570 | Orthovision | Ewoosoft Co., Ltd. | 2013 | — |
| −2 | K173094 | OrthoVision | Ewoosoft Co., Ltd. | 2017 | — |
| −1 | K192888 | EzOrtho | Ewoosoft Co., Ltd. | 2020 | — |
| 0 (this device) | K210187 | Overjet Dental Assist | Overjet, Inc. | 2021 | — |
| +1 | K230144 | Denti.AI Detect | Denti.Ai Technology, Inc. | 2023 | — |
| +1 | K260851 | Better Diagnostics Dental Assist (BDDA) Version 1.0 | Better Diagnostics AI Corp. | 2026 | — |
| +2 | K250525 | Second Opinion® Panoramic | Pearl, Inc. | 2025 | — |
| +1 | K243230 | Second Opinion® BLE | Pearl, Inc. | 2025 | — |
| +1 | K232440 | Adravision Perio | Adra Corporation | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 3 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | K192888 | EzOrthoSummary page 5…mary teeth. Overjet has not evaluated the performance of the device on primary dentition. 8. Predicate Device Device - EZOrtho Manufacturer - Ewoosoft Co., Ltd. 510k - K192888 9. Substantial Equivalence indicated for use by dentists who provide orthodontic treatment for image analysis, simulation, prof… | 2020 |
What descends from it? (6)
5 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?
- The line of descent spans 28 years and passes through 7 companies; a new generation was cleared every 3.0 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K230144 (Denti.Ai Technology, Inc., 2023) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K192888.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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?
Overjet Dental Assist is a radiological semi-automated image processing software device intended to aid dental professionals in the measurements of mesial and distal bone levels associated with each tooth from bitewing and periapical radiographs. It should not be used in-lieu of full patient evaluation or solely relied upon to make or confirm a diagnosis. The system is to be used by trained professionals including, but not limited to, dentists and dental…
Read the full statement (117 words)
Overjet Dental Assist is a radiological semi-automated image processing software device intended to aid dental professionals in the measurements of mesial and distal bone levels associated with each tooth from bitewing and periapical radiographs.
It should not be used in-lieu of full patient evaluation or solely relied upon to make or confirm a diagnosis. The system is to be used by trained professionals including, but not limited to, dentists and dental hygienists.
Intended Patient Population:
The intended patient population of the device is patients living in the United States, who are 22 years old or older, and that do not have any remaining primary teeth. Overjet has not evaluated the performance of the device on primary 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/K210187 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210187: Overjet Dental Assist.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210187
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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