510(k) · Cleared
ClearedOverjet Periapical Radiolucency Assist
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Overjet, Inc. · MYN Analyzer, Medical Image
Cleared on Sep 21, 2023 as substantially equivalent to K221921 (Nobel Biocare AB, 2023) and 1 other predicate after a 104-day review. Its family tree reaches back 3 generations to 1998. 2 later devices descend from it.
- Decided
- Sep 21, 2023
- Review
- 104 days
- Class
- Class II
- Product code
- MYN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to P980025 (1998). 4 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backP980025 Logicon Caries DetectorCarestream Dental, LLC · 1998 · Recalled
- 2 generations backK210365 Second OpinionPearl, Inc. · 2022
- 1 generation backK221921 DTX Studio Clinic 3.0Nobel Biocare AB · 2023
- This deviceK231678 Overjet Periapical Radiolucency AssistOverjet, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK252934 DiagnocatDgnct, LLC · 2026
- Descendant · cites it directly · 0 of its ownK242600 Second Opinion Periapical Radiolucency ContoursPearl, Inc. · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | P980025 | Logicon Caries Detector | Carestream Dental, LLC | 1998 | 1 |
| −2 | K210365 | Second Opinion | Pearl, Inc. | 2022 | — |
| −1 | K221921 | DTX Studio Clinic 3.0 | Nobel Biocare AB | 2023 | — |
| 0 (this device) | K231678 | Overjet Periapical Radiolucency Assist | Overjet, Inc. | 2023 | — |
| +1 | K252934 | Diagnocat | Dgnct, LLC | 2026 | — |
| +1 | K242600 | Second Opinion Periapical Radiolucency Contours | Pearl, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 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 MYN? 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 MYN device
- #1 K210365 Second Opinionscore 29.9 · 1 generation · 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 |
|---|---|---|---|
| * | K221921 | DTX Studio Clinic 3.0Summary page 4…892.2070 Product Code MYN 21 CFR 807.92(a)(3) I Legally Marketed Predicate Devices Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K221921 DTX Studio Clinic 3.0 MYN K210365 Second Opinion® MYN Device Description Summary 21 CFR 807.92(a)(4) Overjet Periapical Radiolu… | 2023 |
| * | K210365 | Second OpinionSummary page 4…R 807.92(a)(3) I Legally Marketed Predicate Devices Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K221921 DTX Studio Clinic 3.0 MYN K210365 Second Opinion® MYN Device Description Summary 21 CFR 807.92(a)(4) Overjet Periapical Radiolucency "PARL" Assist is a module wi… | 2022 |
What descends from it? (2)
2 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 25 years and passes through 4 companies; a new generation was cleared every 1.1 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K252934 (Dgnct, LLC, 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K221921.
How does its category compare?
All MYN devicesMYN Analyzer, Medical Image: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · MYN
14in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MYN
210in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MYN
No recall names MYN since 2007.
Adverse event reports per year · MYN
2in 2025
MAUDE reports naming product code MYN, 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 | 5 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 6 | — | 0 | 0 |
| 2013 | 4 | — | 0 | 0 |
| 2014 | 3 | — | 0 | 0 |
| 2015 | 3 | — | 0 | 0 |
| 2016 | 2 | — | 0 | 0 |
| 2017 | 3 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 2 | — | 0 | 0 |
| 2022 | 5 | 273 | 0 | 0 |
| 2023 | 10 | 229 | 0 | 0 |
| 2024 | 2 | — | 0 | 1 |
| 2025 | 14 | 210 | 0 | 2 |
| 2026 | 7 | 128 | 0 | — |
What is it indicated for?
Overjet Periapical Radiolucency (PARL) Assist is a radiological, automated, concurrent read computer-assisted detection software intended to aid in the detection of periapical radiolucencies on permanent teeth captured on periapical radiographs. The device provides additional aid for the dentist to use in their identification of periapical radiolucency. The device is not intended as a replacement for a complete dentist’s review or their clinical judgment…
Read the full statement (104 words)
Overjet Periapical Radiolucency (PARL) Assist is a radiological, automated, concurrent read computer-assisted detection software intended to aid in the detection of periapical radiolucencies on permanent teeth captured on periapical radiographs. The device provides additional aid for the dentist to use in their identification of periapical radiolucency. The device is not intended as a replacement for a complete dentist’s review or their clinical judgment that considers other relevant information from the image or patient history. The system is to be used by professionally trained and licensed dentists.
The Overjet Periapical Radiolucency Assist software is indicated for use on patients 12 years of age or older.
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/K231678 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231678: Overjet Periapical Radiolucency Assist.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231678
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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