Better Diagnostics Dental Assist (BDDA) Version 1.0— 510(k) K260851
Substantially EquivalentBetter 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.
Summary
Better Diagnostics AI's Better Diagnostics Dental Assist (BDDA) Version 1.0 is filed under MYN, medical image analyzers. The record doesn't describe what the software analyzes or outputs.
Class II, 21 CFR 892.2070. Radiology is both the classification panel and the review panel, and it was a Traditional 510(k).
Better Diagnostics AI filed from Avon, Connecticut. Review took 121 calendar days (March 16 to July 15, 2026).
Clearance details
- Applicant
- Better Diagnostics AI Corp.
- Product code
- Product code MYN
- Device class
- Class 2
- Regulation
- 21 CFR 892.2070
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Avon, CT, US
Recent devices under product code MYN
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