Medical Device Manufacturer · US , York , PA

Dentsply Sirona - FDA 510(k) Cleared Devices

65 submissions · 65 cleared · Since 2016

Recent clearances: DS Core CBCT Anatomy, Primevision 3D, Atlantis® Abutments in Titanium

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65

Total

65

Cleared

0

Denied

FDA 510(k) Regulatory Record - Dentsply Sirona Radiology ✕

7 devices

1-7 of 7

Cleared Apr 23, 2026

DS Core CBCT Anatomy

Radiology · 44d

Cleared Feb 05, 2026

Radiology · 57d

Cleared Jun 22, 2020

Radiology · 54d

Cleared Jul 16, 2019

Radiology · 28d

Cleared Apr 04, 2018

Radiology · 252d

Cleared Jul 17, 2017

3D Endo Software

Radiology · 94d

Cleared Jul 28, 2016

SIMPLANT Online Case Review and SIMPLANT Editor

Radiology · 99d