Videa Dental AI

Q: When was Videa Dental AI cleared by the FDA?

Videa Dental AI (K251002) received a 510(k) decision of Substantially Equivalent on September 19, 2025, 171 days after the submission was received.

Q: What is the product code of K251002?

The FDA product code is MYN – Analyzer, Medical Image, a Class II (moderate risk) device regulated under 21 CFR 892.2070.

FDA 510(k) K251002 · Videahealth, Inc.

Substantially Equivalent

510(k) numberK251002

Submission

Device name: Videa Dental AI
Applicant: Videahealth, Inc.
Boston, MA, US
Received: April 1, 2025
Decision date: September 19, 2025
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: MYN – Analyzer, Medical Image
Device class: Class II (moderate risk)
Regulation: 21 CFR 892.2070
Specialty: Radiology

For information on the MYN device, please see: https://www.federalregister.gov/documents/2020/01/22/2020-00494/radiology-devices-reclassification-of-medical-image-analyzers

Other 510(k)s with product code MYN

510(k)	Device	Applicant	Decision
K252486	ChestView US (1.1)MYN · Traditional	Gleamer	09/09/2026SE
K261059	Overjet Multi-Image Caries and Charting AssistMYN · Traditional	Overjet, Inc.	08/06/2026SE
K260851	Better Diagnostics Dental Assist (BDDA) Version 1.0MYN · Traditional	Better Diagnostics AI Corp.	07/15/2026SE
K252953	Velmeni for Dentists (V4D) Endo-PerioMYN · Traditional	Velmeni, Inc.	05/11/2026SE
K251934	qXR-DetectMYN · Traditional	Qure.Ai Technologies	01/16/2026SE
K252934	DiagnocatMYN · Traditional	Dgnct, LLC	01/15/2026SE
K253009	DS Core DetectMYN · Traditional	Dentsply Sirona, Inc.	01/07/2026SE
K252086	DTX Studio AssistMYN · Traditional	Nobel Biocare C/O Medicim NV	11/17/2025SE
K250525	Second Opinion® PanoramicMYN · Traditional	Pearl, Inc.	11/14/2025SE
K250264	SugarBug (1.x)MYN · Traditional	Bench7, Inc.	11/07/2025SE

More from Bench7, Inc.

510(k)	Device	Decision
K232384	Videa Dental AssistMYN · Traditional	12/15/2023SE
K223296	Videa Perio AssistQIH · Traditional	02/06/2023SE
K213795	Videa Caries AssistMYN · Traditional	04/21/2022SE

Questions and answers

When was Videa Dental AI cleared by the FDA?

Videa Dental AI (K251002) received a 510(k) decision of Substantially Equivalent on September 19, 2025, 171 days after the submission was received.

What is the product code of K251002?

The FDA product code is MYN – Analyzer, Medical Image, a Class II (moderate risk) device regulated under 21 CFR 892.2070.