Medical Device Manufacturer · US , N. Attleboro , MA

Sirona Dental Systems GmbH - FDA 510(k) Cleared Devices

42 submissions · 42 cleared · Since 1998

42

Total

42

Cleared

0

Denied

FDA 510(k) Regulatory Record - Sirona Dental Systems GmbH Radiology ✕

14 devices

1-14 of 14

Cleared May 08, 2015

Radiology · 98d

Cleared Dec 11, 2013

Radiology · 97d

Cleared Mar 15, 2013

GALILEOS FAMILY

Radiology · 165d

Cleared Mar 22, 2011

ORTHOPHOS XG 3D / CEPH

Radiology · 92d

Cleared Dec 23, 2008

Radiology · 40d

Cleared Aug 26, 2008

XIOS PLUS WALL-MODULE

Radiology · 54d

Cleared Apr 14, 2006

Radiology · 11d

Cleared Oct 10, 2003

ORTHOPHOS XG DS/CEPH

Radiology · 11d

Cleared Dec 06, 2001

ORTHOPHOS DS/DC CEPH, ORTHOPHOS 5/PLUS/CD

Radiology · 30d

Cleared Dec 06, 2001

MODIFICATION TO SIDEXIS DIGITAL RADIOGRAPHY IMAGING SYSTEM

Radiology · 30d

Cleared May 02, 2000

HELIODENT VARIO

Radiology · 64d

Cleared Aug 23, 1999

SIDEXIS DIGITAL RADIOGRAPHY IMAGING SYSTEM

Radiology · 17d

Cleared Apr 30, 1999

ORTHOPHOS 3/3 CEPH/3 DS

Radiology · 70d

Cleared Oct 22, 1998

ORTHOPHOS 5/PLUS/CD

Radiology · 51d