DS Core Detect
FDA 510(k) K253009 · Dentsply Sirona, Inc.
510(k) numberK253009
Submission
- Device name
- DS Core Detect
- Applicant
- Dentsply Sirona, Inc.
York, PA, US - Received
- September 19, 2025
- Decision date
- January 7, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MYN – Analyzer, Medical Image
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 892.2070
- Specialty
- Radiology
For information on the MYN device, please see: https://www.federalregister.gov/documents/2020/01/22/2020-00494/radiology-devices-reclassification-of-medical-image-analyzers
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| K260851 | Better Diagnostics Dental Assist (BDDA) Version 1.0MYN · Traditional | Better Diagnostics AI Corp. | 07/15/2026SE |
| K252953 | Velmeni for Dentists (V4D) Endo-PerioMYN · Traditional | Velmeni, Inc. | 05/11/2026SE |
| K251934 | qXR-DetectMYN · Traditional | Qure.Ai Technologies | 01/16/2026SE |
| K252934 | DiagnocatMYN · Traditional | Dgnct, LLC | 01/15/2026SE |
| K252086 | DTX Studio AssistMYN · Traditional | Nobel Biocare C/O Medicim NV | 11/17/2025SE |
| K250525 | Second Opinion® PanoramicMYN · Traditional | Pearl, Inc. | 11/14/2025SE |
| K250264 | SugarBug (1.x)MYN · Traditional | Bench7, Inc. | 11/07/2025SE |
| K251002 | Videa Dental AIMYN · Traditional | Videahealth, Inc. | 09/19/2025SE |
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| K253959 | Primevision 3DOAS · Traditional | 02/05/2026SE |
| K252343 | Atlantis® Abutments in TitaniumNHA · Traditional | 12/09/2025SE |
| K252248 | CEREC Tessera Abutment SystemNHA · Traditional | 11/26/2025SE |
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Questions and answers
When was DS Core Detect cleared by the FDA?
DS Core Detect (K253009) received a 510(k) decision of Substantially Equivalent on January 7, 2026, 110 days after the submission was received.
What is the product code of K253009?
The FDA product code is MYN – Analyzer, Medical Image, a Class II (moderate risk) device regulated under 21 CFR 892.2070.