510(k) · Cleared
ClearedVidea Dental Assist
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Videahealth, Inc. · MYN Analyzer, Medical Image
Cleared on Dec 15, 2023 as substantially equivalent to K213795 (Videahealth, Inc., 2022) after a 129-day review. Its family tree reaches back 2 generations to 1998. 2 later devices descend from it.
- Decided
- Dec 15, 2023
- Review
- 129 days
- Class
- Class II
- Product code
- MYN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to P980025 (1998). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backP980025 Logicon Caries DetectorCarestream Dental, LLC · 1998 · Recalled
- 1 generation backK213795 Videa Caries AssistVideahealth, Inc. · 2022
- This deviceK232384 Videa Dental AssistVideahealth, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK253009 DS Core DetectDentsply Sirona, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK251002 Videa Dental AIVideahealth, 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 |
|---|---|---|---|---|---|
| −2 | P980025 | Logicon Caries Detector | Carestream Dental, LLC | 1998 | 1 |
| −1 | K213795 | Videa Caries Assist | Videahealth, Inc. | 2022 | — |
| 0 (this device) | K232384 | Videa Dental Assist | Videahealth, Inc. | 2023 | — |
| +1 | K253009 | DS Core Detect | Dentsply Sirona, Inc. | 2026 | — |
| +1 | K251002 | Videa Dental AI | Videahealth, Inc. | 2025 | — |
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? (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 |
|---|---|---|---|
| * | K213795 | Videa Caries AssistSummary page 6…ication Regulation 21 CFR 892.2070 Number: Device Class: 2 Product Code: MYN 3. PREDICATE DEVICE Predicate Device: K213795 VideaHealth’s Videa Caries Assist (VCA) 4. DEVICE DESCRIPTION Videa Dental Assist (VDA) software is a cloud-based AI-p… | 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 2 companies; a new generation was cleared every 23.6 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K253009 (Dentsply Sirona, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K213795.
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?
Videa Dental Assist is a computer-assisted detection (CADe) device that analyzes intraoral radiographs to identify and localize the following features. Videa Dental Assist is indicated for the review of bitewing, periapical, and panoramic radiographs acquired from patients aged 3 years or older. Suspected Dental Findings: ● Caries ● Attrition ● Broken/Chipped Tooth ● Restorative Imperfections ● Pulp Stones ● Dens Invaginatus ● Periapical Radiolucency ●…
Read the full statement (144 words)
Videa Dental Assist is a computer-assisted detection (CADe) device that analyzes intraoral radiographs to identify and
localize the following features. Videa Dental Assist is indicated for the review of bitewing, periapical, and panoramic
radiographs acquired from patients aged 3 years or older.
Suspected Dental Findings:
● Caries
● Attrition
● Broken/Chipped Tooth
● Restorative Imperfections
● Pulp Stones
● Dens Invaginatus
● Periapical Radiolucency
● Widened Periodontal Ligament
● Furcation
● Calculus
Historical Treatments:
● Crown
● Filling
● Bridge
● Post and Core
● Root Canal
● Endosteal Implant
● Implant Abutment
● Bonded Orthodontic Retainer
● Braces
Normal Anatomy:
● Maxillary Sinus
● Maxillary Tuberosity
● Mental Foramen
● Mandibular Canal
● Inferior Border of the Mandible
● Mandibular Tori
● Mandibular Condyle
● Developing Teeth
● Erupting Teeth
● Non-matured Erupted Teeth
● Exfoliating Teeth
● Impacted Teeth
● Crowding Teeth
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232384 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232384: Videa 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/K232384
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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