Sirona Dental Systems GmbH is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
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
Sirona Dental Systems GmbH has 42 FDA 510(k) cleared medical devices. Based in N. Attleboro, US.
Historical record: 42 cleared submissions from 1998 to 2016. Primary specialty: Dental.
Browse the FDA 510(k) cleared devices submitted by Sirona Dental Systems GmbH Filter by specialty or product code using the sidebar.
Regulatory submissions have been managed by Sirona Dental Systems, Inc., Tuv America, Inc. and Tuv Sud America, Inc..
FDA 510(k) Regulatory Record - Sirona Dental Systems GmbH
42 devices
Cleared
Jun 02, 2016
CEREC SpeedGlaze
Dental
135d
Cleared
Jul 24, 2015
TENEO Dental Treatment Unit and Accessories
Dental
95d
Cleared
Jul 17, 2015
INTEGO Family and Accesories
Dental
105d
Cleared
Jul 02, 2015
Endo 6:1, T1 Line Endo 6 L, SIRONiTi Apex, T1 Spray
Dental
101d
Cleared
May 08, 2015
ORTHOPHOS SL
Radiology
98d
Cleared
May 30, 2014
T1/T2/T3 TURBINE FAMILY
Dental
388d
Cleared
Dec 11, 2013
SIDEXIS 4
Radiology
97d
Cleared
Apr 08, 2013
INCORIS ZI
Dental
131d
Cleared
Mar 20, 2013
CEREC BLOCS C IN
Dental
89d
Cleared
Mar 15, 2013
GALILEOS FAMILY
Radiology
165d
Cleared
Feb 01, 2013
INCORIS TZI
Dental
74d
Cleared
Feb 17, 2012
SIRONA DENTAL CAD/CAM SYSTEM
Dental
273d
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