Sirona Dental Systems GmbH - FDA 510(k) Cleared Devices
Recent clearances: CEREC SpeedGlaze, TENEO Dental Treatment Unit and Accessories, INTEGO Family and Accesories
42
Total
42
Cleared
0
Denied
FDA 510(k) Regulatory Record - Sirona Dental Systems GmbH Radiology ✕
14 devices
Cleared
May 08, 2015
ORTHOPHOS SL
Radiology
98d
Cleared
Dec 11, 2013
SIDEXIS 4
Radiology
97d
Cleared
Mar 15, 2013
GALILEOS FAMILY
Radiology
165d
Cleared
Mar 22, 2011
ORTHOPHOS XG 3D / CEPH
Radiology
92d
Cleared
Dec 23, 2008
HELIODENT PLUS
Radiology
40d
Cleared
Aug 26, 2008
XIOS PLUS WALL-MODULE
Radiology
54d
Cleared
Apr 14, 2006
GALILEOS
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