510(k) clearance

DS Core Detect

FDA 510(k) source

510(k) number

K261072

Applicant

Dentsply Sirona, Inc.

Decision date

Oct 30, 2026

Date received

Apr 1, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

MYN

Device type

Analyzer, Medical Image

Device class

Class II

Regulation

21 CFR 892.2070

Advisory committee

Radiology

Statement or summary

Summary

Third party

N

Location

York, PA, US