Better Diagnostics Dental Assist (BDDA) Version 1.0— 510(k) K260851

Name: FDA 510(k) clearance K260851
Creator: U.S. Food and Drug Administration
Published: 2026-07-15

Substantially Equivalent

Better Diagnostics AI Corp.

FDA 510(k) clearance K260851 for Better Diagnostics Dental Assist (BDDA) Version 1.0, Substantially Equivalent on 2026-07-15. Applicant: Better Diagnostics AI Corp.. Device class: 2.

Clearance details

Applicant: Better Diagnostics AI Corp.
Product code: Code MYN
Device class: Class 2
Regulation: 21 CFR 892.2070
Advisory panel: Radiology
Date received: 2026-03-16
Decision date: 2026-07-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Avon, CT, US

Download summary PDF View on FDA.gov ↗

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