Better Diagnostics Dental Assist (BDDA) Version 1.0
Summary
Better Diagnostics AI Corp. received 510(k) clearance for Better Diagnostics Dental Assist (BDDA) Version 1.0, a MYN device. Cleared on 2026-07-15.
Details
Source
510(k) Clearance
External ID
K260851
Action Date
2026-07-15
Status
Traditional
Category
device
Product Code
MYN
Product Description
Better Diagnostics Dental Assist (BDDA) Version 1.0. Product code: MYN.
Company
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 365 device clearances issued this month. Better Diagnostics AI Corp. has received 2 total clearances in our database.
Better Diagnostics AI Corp. has 2 FDA actions in our database, including 2 clearances.
Frequently Asked Questions
What does 510(k) clearance mean?
A 510(k) is an FDA premarket submission demonstrating that a device is substantially equivalent to a legally marketed device. It does NOT mean FDA approval — it means the device is cleared for marketing because it's similar enough to an existing cleared device. Most medical devices reach market via 510(k) rather than full PMA approval.
How often does Better Diagnostics AI Corp. have FDA actions?
Better Diagnostics AI Corp. has 2 FDA actions in our database, including 0 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K260851" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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