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FDA 510(k)

Better Diagnostics Caries Assist (BDCA) Version 1.0

K-Number: K241725 · 2025-03-11

ApplicantBetter Diagnostics AI Corp.
Decision Date2025-03-11
Product CodeMYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Better Diagnostics Caries Assist (BDCA) 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 2025-03-11 under 510(k) number K241725. 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 Caries Assist (BDCA) Version 1.0?

Better Diagnostics Caries Assist (BDCA) Version 1.0 is a medical device that received FDA 510(k) clearance on 2025-03-11. The listed applicant is Better Diagnostics AI Corp.. The 510(k) number is K241725.

When did Better Diagnostics Caries Assist (BDCA) Version 1.0 receive FDA 510(k) clearance?

Better Diagnostics Caries Assist (BDCA) Version 1.0 received FDA 510(k) clearance on 2025-03-11, under 510(k) number K241725.

Who is the listed applicant for Better Diagnostics Caries Assist (BDCA) 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 Caries Assist (BDCA) Version 1.0?

The FDA product code for Better Diagnostics Caries Assist (BDCA) 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.

K260851Better Diagnostics Dental Assist (BDDA) 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.

K261059Overjet Multi-Image Caries and Charting AssistOverjet, Inc.K260851Better Diagnostics Dental Assist (BDDA) Version 1.0Better Diagnostics AI Corp.K252953Velmeni for Dentists (V4D) Endo-PerioVelmeni, Inc.K251934qXR-DetectQure.Ai TechnologiesK252934DiagnocatDGNCT, LLCK253009DS Core DetectDentsply Sirona, 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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