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 Dental ✕

25 devices

1-25 of 25

Cleared Jun 02, 2016

CEREC SpeedGlaze

Cleared Jul 24, 2015

TENEO Dental Treatment Unit and Accessories

Cleared Jul 17, 2015

INTEGO Family and Accesories

Cleared Jul 02, 2015

Endo 6:1, T1 Line Endo 6 L, SIRONiTi Apex, T1 Spray

Cleared May 30, 2014

T1/T2/T3 TURBINE FAMILY

Cleared Apr 08, 2013

Cleared Mar 20, 2013

CEREC BLOCS C IN

Cleared Feb 01, 2013

Cleared Feb 17, 2012

SIRONA DENTAL CAD/CAM SYSTEM

Cleared Oct 22, 2010

SIRONA CAD/CAM SYSTEM

Cleared Apr 11, 2008

CEREC OPTI SPRAY

Cleared Feb 14, 2008

PERIOSCAN, MODEL: D 3496

Cleared Sep 12, 2006

Cleared Sep 08, 2006

Cleared Mar 31, 2006

Cleared Sep 06, 2005

IMPLANT HANDPIECES

Cleared Mar 21, 2005

PERIOSCAN ULTRASONIC SCALER

Cleared Feb 23, 2004

SIROAIR L AIR SCALER

Cleared Jan 15, 2004

PROSMILE AIR POLISHER AND PROPHYLAXIS POWDER

Cleared Dec 12, 2003

SIROSON L AND SIROSONIC L ULTRASONIC SCALERS

Cleared Nov 14, 2003

SIRONA DENTAL SYSTEMS C8+DENTAL OPERATIVE UNIT WITH ACCESSORIES

Cleared Aug 19, 2003

Cleared Nov 01, 2001

CEREC3 VITABLOCKS

Cleared Feb 08, 2000

Cleared Dec 11, 1998

SIRONA C8 DENTAL OPERATIVE UNIT WITH ACCESSORIES