DS Core CBCT Anatomy— 510(k) K262127

Name: FDA 510(k) clearance K262127
Creator: U.S. Food and Drug Administration
Published: 2026-08-21

Substantially Equivalent

Dentsply Sirona

FDA 510(k) clearance K262127 for DS Core CBCT Anatomy, Substantially Equivalent on 2026-08-21. 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 expand CBCT or describe the product further.

Class II, 21 CFR 892.2050. Radiology is both the classification panel and the review panel. It came in as a Traditional 510(k).

Dentsply Sirona filed from York, Pennsylvania. Review took 58 calendar days (June 24 to August 21, 2026), ending in a substantially equivalent decision.

Clearance details

Applicant: Dentsply Sirona
Product code: Product code QIH
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2026-06-24
Decision date: 2026-08-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: York, PA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.