DS Core CBCT Anatomy— 510(k) K260785
Substantially EquivalentDentsply Sirona
FDA 510(k) clearance K260785 for DS Core CBCT Anatomy, Substantially Equivalent on 2026-04-23. Applicant: Dentsply Sirona. Device class: 2.
Summary
Dentsply Sirona's DS Core CBCT Anatomy is filed under product code QIH (Automated Radiological Image Processing Software). The record doesn't describe the software beyond its name and that code name.
Class II, 21 CFR 892.2050. Radiology is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Dentsply Sirona filed from York, Pennsylvania. The decision came 44 calendar days after FDA received it (March 10 to April 23, 2026).
Clearance details
- Applicant
- Dentsply Sirona
- Product code
- Product code QIH
- Device class
- Class 2
- Regulation
- 21 CFR 892.2050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- York, PA, US
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