When did DS Core Detect receive FDA clearance or approval?

DS Core Detect (Submission ID: K261072) was fda cleared by the U.S. FDA on 2026-10-30 under the 510K pathway with a review duration of 212 days.

Who is the manufacturer or applicant for DS Core Detect?

The applicant and sponsor for K261072 is Dentsply Sirona, Inc..

No. This medical device submission is not designated as incorporating AI/ML software algorithms.

FDA Cleared New Device Pathway: 510K

Applicant: Dentsply Sirona, Inc. XRAY

Legal Standard:

Substantial Equivalence (SE) to predicate (21 CFR 807)

Product Code:

MYN

Review Panel:

Radiology

21 CFR Regulation:

Date Received:

2026-04-01

Decision Date:

2026-10-30

Total Review Duration:

212 calendar days (212 days)

Direct links to primary official records hosted by the U.S. Food and Drug Administration CDRH databases:

Deepthi Paknikar

Role: SUBMITTER_CONTACT

Notice a discrepancy or outdated information on this record?