510(k) · Cleared

Cleared

Videa Dental AI

K251002510(k) TraditionalCleared Sep 19, 2025171-day reviewClass II21 CFR 892.2070

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Videahealth, Inc. · MYN Analyzer, Medical Image

Cleared on Sep 19, 2025 as substantially equivalent to K232384 (Videahealth, Inc., 2023) after a 171-day review. Its family tree reaches back 3 generations to 1998.

Decided: Sep 19, 2025
Review: 171 days
Class: Class II
Product code: MYN
Recalls: None
Predicates: 1

Its longest line of descent runs back 3 generations to P980025 (1998). No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backP980025 Logicon Caries DetectorCarestream Dental, LLC · 1998 · Recalled
2 generations backK213795 Videa Caries AssistVideahealth, Inc. · 2022
1 generation backK232384 Videa Dental AssistVideahealth, Inc. · 2023
This deviceK251002 Videa Dental AIVideahealth, Inc. · 2025

View 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	K213795	Videa Caries Assist	Videahealth, Inc.	2022	—
−1	K232384	Videa Dental Assist	Videahealth, Inc.	2023	—
0 (this device)	K251002	Videa Dental AI	Videahealth, Inc.	2025	—

FIG. 1 — Lineage of K251002, 1998–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K232384	Videa Dental Assist Summary page 6 …ication Regulation 21 CFR 892.2070 Number: Device Class: 2 Product Code: MYN 3. PREDICATE DEVICE Predicate Device: K232384 VideaHealth’s Videa Dental Assist 510(k) Summary …	Videahealth, Inc.	2023	—

Also cleared against K232384: 1 other device →

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?

The line of descent spans 27 years and passes through 2 companies; a new generation was cleared every 1.8 years on median.
1 of the 3 ancestors has a recall of any class.
1 other device also cites its predicate K232384.

How does its category compare?

All MYN devices

MYN Analyzer, Medical Image: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.

FDA decisions per year · MYN

14in 2025

2007high 14 (2025) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MYN

210in 2025

2007high 273 (2022) · low 210 (2025)2026

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

2007high 2 (2025) · low 0 (2007)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	MAUDE reports
2007	5	—	0
2008	2	—	0
2009	0	—	0
2010	2	—	0
2011	1	—	0
2012	6	—	0
2013	4	—	0
2014	3	—	0
2015	3	—	0
2016	2	—	0
2017	3	—	0
2018	0	—	1
2019	1	—	0
2020	0	—	0
2021	2	—	0
2022	5	273	0
2023	10	229	0
2024	2	—	1
2025	14	210	2
2026	7	128	—

What is it indicated for?

Videa Dental AI is a computer-assisted detection (CADe) device that analyzes intraoral radiographs to identify and localize the following features. Videa Dental AI 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 Imperfection - Pulp Stones - Dens Invaginatus - Periapical Radiolucency - Widened…

Read the full statement (144 words)

Suspected Dental Findings:

- Caries

- Attrition

- Broken/Chipped Tooth

- Restorative Imperfection

- 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 Tooth

- 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/K251002 · printed Nov 6, 2026

Cite this page

510(k) Report. “K251002: Videa Dental AI.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K251002

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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