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FDA 510(k)

Better Diagnostics Dental Assist (BDDA) Version 1.0

K-Number: K260851 · 2026-07-15

ApplicantBetter Diagnostics AI Corp.
Decision Date2026-07-15
Product CodeMYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Better Diagnostics Dental Assist (BDDA) Version 1.0 is the device name listed in this FDA 510(k) record. The listed applicant is Better Diagnostics AI Corp.. It received FDA 510(k) clearance on 2026-07-15 under 510(k) number K260851. The device is classified under product code MYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Better Diagnostics Dental Assist (BDDA) Version 1.0?

Better Diagnostics Dental Assist (BDDA) Version 1.0 is a medical device that received FDA 510(k) clearance on 2026-07-15. The listed applicant is Better Diagnostics AI Corp.. The 510(k) number is K260851.

When did Better Diagnostics Dental Assist (BDDA) Version 1.0 receive FDA 510(k) clearance?

Better Diagnostics Dental Assist (BDDA) Version 1.0 received FDA 510(k) clearance on 2026-07-15, under 510(k) number K260851.

Who is the listed applicant for Better Diagnostics Dental Assist (BDDA) Version 1.0?

The FDA 510(k) record lists Better Diagnostics AI Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Better Diagnostics Dental Assist (BDDA) Version 1.0?

The FDA product code for Better Diagnostics Dental Assist (BDDA) Version 1.0 is MYN.

Other records listing Better Diagnostics AI Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K241725Better Diagnostics Caries Assist (BDCA) Version 1.0

Related Devices (Code: MYN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252953Velmeni for Dentists (V4D) Endo-PerioVelmeni, Inc.K251934qXR-DetectQure.Ai TechnologiesK252934DiagnocatDGNCT, LLCK253009DS Core DetectDentsply Sirona, Inc.K252086DTX Studio AssistNobel Biocare C/O Medicim NVK250525Second Opinion® PanoramicPearl, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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