Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

42 results for "Sirona Dental Systems GmbH"
1–24 of 42
Search insights Median review: 76d Cleared: 100% Top manufacturer: Sirona Dental Systems GmbH Lead specialty: Dental
Cleared Jun 02, 2016
CEREC SpeedGlaze
K160099 · EIH
Sirona Dental Systems GmbH
Dental · 135d
Cleared Jul 24, 2015
TENEO Dental Treatment Unit and Accessories
K151045 · EIA
Sirona Dental Systems GmbH
Dental · 95d
Cleared Jul 17, 2015
INTEGO Family and Accesories
K150909 · EIA
Sirona Dental Systems GmbH
Dental · 105d
Cleared Jul 02, 2015
Endo 6:1, T1 Line Endo 6 L, SIRONiTi Apex, T1 Spray
K150750 · EGS
Sirona Dental Systems GmbH
Dental · 101d
Cleared May 08, 2015
ORTHOPHOS SL
K150217 · OAS
Sirona Dental Systems GmbH
Radiology · 98d
Cleared May 30, 2014
T1/T2/T3 TURBINE FAMILY
K131319 · EFB
Sirona Dental Systems GmbH
Dental · 388d
Cleared Dec 11, 2013
SIDEXIS 4
K132773 · LLZ
Sirona Dental Systems GmbH
Radiology · 97d
Cleared Apr 08, 2013
INCORIS ZI
K123664 · EIH
Sirona Dental Systems GmbH
Dental · 131d
Cleared Mar 20, 2013
CEREC BLOCS C IN
K123952 · EIH
Sirona Dental Systems GmbH
Dental · 89d
Cleared Mar 15, 2013
GALILEOS FAMILY
K123070 · OAS
Sirona Dental Systems GmbH
Radiology · 165d
Cleared Feb 01, 2013
INCORIS TZI
K123545 · EIH
Sirona Dental Systems GmbH
Dental · 74d
Cleared Feb 17, 2012
SIRONA DENTAL CAD/CAM SYSTEM
K111421 · NHA
Sirona Dental Systems GmbH
Dental · 273d
Cleared Mar 22, 2011
ORTHOPHOS XG 3D / CEPH
K103711 · OAS
Sirona Dental Systems GmbH
Radiology · 92d
Cleared Feb 15, 2011
SIROLASER ADVANCE, SIROLASER XTEND, SIROLASER XTEND UPGRADED, FONALASER
K103753 · GEX
Sirona Dental Systems GmbH
General & Plastic Surgery · 54d
Cleared Oct 22, 2010
SIRONA CAD/CAM SYSTEM
K100152 · NHA
Sirona Dental Systems GmbH
Dental · 276d
Cleared Dec 03, 2009
SIROLASER ADVANCE
K092660 · GEX
Sirona Dental Systems GmbH
General & Plastic Surgery · 97d
Cleared Dec 23, 2008
HELIODENT PLUS
K083344 · EHD
Sirona Dental Systems GmbH
Radiology · 40d
Cleared Aug 26, 2008
XIOS PLUS WALL-MODULE
K081903 · MUH
Sirona Dental Systems GmbH
Radiology · 54d
Cleared Apr 11, 2008
CEREC OPTI SPRAY
K080882 · ELW
Sirona Dental Systems GmbH
Dental · 11d
Cleared Feb 14, 2008
PERIOSCAN, MODEL: D 3496
K072107 · ELC
Sirona Dental Systems GmbH
Dental · 198d
Cleared Sep 12, 2006
INCORIS ZI
K062509 · EIH
Sirona Dental Systems GmbH
Dental · 15d
Cleared Sep 08, 2006
INCORIS AL
K062506 · EIH
Sirona Dental Systems GmbH
Dental · 11d
Cleared Apr 14, 2006
GALILEOS
K060892 · MUH
Sirona Dental Systems GmbH
Radiology · 11d
Cleared Mar 31, 2006
SIROENDO
K052515 · EKX
Sirona Dental Systems GmbH
Dental · 198d