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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 a medical device manufactured by Better Diagnostics AI Corp.. It received FDA 510(k) clearance on 2025-03-11 under approval 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. It is manufactured by Better Diagnostics AI Corp.. The 510(k) number is K241725.

When was Better Diagnostics Caries Assist (BDCA) Version 1.0 approved by the FDA?

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

What company makes Better Diagnostics Caries Assist (BDCA) Version 1.0?

Better Diagnostics Caries Assist (BDCA) Version 1.0 is manufactured by Better Diagnostics AI Corp..

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.

Related Clinical Trials

NCT03331380 Technical Development of Cardiovascular Magnetic Resonance Imaging (CMR) Using a Low Specific Absorption Rate (SAR) Scanner System RECRUITING NCT02382861 Conventional vs Neurally Adjusted Ventilatory Assist in Difficult Weaning From Mechanical Ventilation COMPLETED NCT05933161 A Study of Glycemic Control in Left Ventricular Assist RECRUITING NCT04768322 LVAD Versus GDMT in Ambulatory Advanced Heart Failure Patients RECRUITING NCT05643144 Enhancing Shared Decision-making to Guide Care for People With Dementia and Diabetes RECRUITING NCT07550179 Labial White Spot Lesions and Proximal Caries Development in Orthodontic Patients Using Clear Aligners Versus Traditional Braces. COMPLETED

Related PubMed Literature

PMID: 40060767 Recent regulatory developments in EU Medical Device Regulation and their impact on biomaterials translation. Bioengineering & translational medicine (2025)

Related Devices (Code: MYN)

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Official Source

View on FDA Database →

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

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