510(k) · Cleared
ClearedOverjet Calculus 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 Dec 16, 2022 as substantially equivalent to P980025 (Carestream Dental, LLC, 1998) after a 260-day review. Its family tree reaches back 1 generation to 1998.
- Decided
- Dec 16, 2022
- Review
- 260 days
- Class
- Class II
- Product code
- MYN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to P980025 (1998). No later device cites it as a predicate yet.
- Root · 1 generation backP980025 Logicon Caries DetectorCarestream Dental, LLC · 1998 · Recalled
- This deviceK220928 Overjet Calculus AssistOverjet, Inc. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | P980025 | Logicon Caries Detector | Carestream Dental, LLC | 1998 | 1 |
| 0 (this device) | K220928 | Overjet Calculus Assist | Overjet, Inc. | 2022 | — |
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 30.0 · 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? (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 |
|---|---|---|---|
| * | P980025 | Logicon Caries DetectorSummary page 5…em is to be used by professionally trained and licensed dentists. 8. Predicate Device Device: Logicon Caries Detector Manufacturer - Carestream Dental PMA:P980025 (down-classified to class 2 under 85 FR 3548, Jan. 22, 2020) 9. Substantial Equivalence Device Cares… | 1998 |
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?
- Its one ancestor has a recall.
- 3 other devices also cite its predicate P980025.
How does its category compare?
All MYN devicesMYN Analyzer, Medical Image: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 Calculus Assist (OCalA) is a radiological automated concurrent-read computer-assisted detection software intended to aid in the detection of interproximal calculus deposits on both bitewing and periapical radiographs. The Overjet Calculus Assist surrounds suspected calculus deposits with a bounding box. The device provides additional information for the dentist to use in their diagnosis of a tooth surface suspected of containing calculus…
Read the full statement (104 words)
Overjet Calculus Assist (OCalA) is a radiological automated concurrent-read computer-assisted detection software intended to aid in the detection of interproximal calculus deposits on both bitewing and periapical radiographs. The Overjet Calculus Assist surrounds suspected calculus deposits with a bounding box. The device provides additional information for the dentist to use in their diagnosis of a tooth surface suspected of containing calculus deposits. The device is not intended as a replacement for a complete dentist’s review or their clinical judgment that takes into account other relevant information from the image or patient history. The system is to be used by professionally trained and licensed dentists.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220928 · printed Nov 4, 2026
Cite this page
510(k) Report. “K220928: Overjet Calculus Assist.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K220928
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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