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FDA 510(k)

DS Core CBCT Anatomy

K-Number: K260785 · 2026-04-23

Decision Date2026-04-23
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DS Core CBCT Anatomy is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Sirona. It received FDA 510(k) clearance on 2026-04-23 under 510(k) number K260785. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DS Core CBCT Anatomy?

DS Core CBCT Anatomy is a medical device that received FDA 510(k) clearance on 2026-04-23. The listed applicant is Dentsply Sirona. The 510(k) number is K260785.

When did DS Core CBCT Anatomy receive FDA 510(k) clearance?

DS Core CBCT Anatomy received FDA 510(k) clearance on 2026-04-23, under 510(k) number K260785.

Who is the listed applicant for DS Core CBCT Anatomy?

The FDA 510(k) record lists Dentsply Sirona as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DS Core CBCT Anatomy?

The FDA product code for DS Core CBCT Anatomy is QIH.

Other records listing Dentsply Sirona 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.

View all 86 devices →

Related Devices (Code: QIH)

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.

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.