Medical Device Manufacturer · US , N. Attleboro , MA

Sirona Dental Systems GmbH

42 submissions · 42 cleared · Since 1998
42
Total
42
Cleared
0
Denied

Sirona Dental Systems GmbH — FDA 510(k) Submissions

Sirona Dental Systems GmbH has submitted 42 FDA 510(k) premarket notifications since 1998, of which 42 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include System, X-ray, Extraoral Source, Digital, Powder, Porcelain, Unit, Operative Dental, Unit, X-ray, Extraoral With Timer, Material, Impression . Use the specialty filter in the sidebar to narrow results.

42 devices
1–25 of 42
CEREC SpeedGlaze
K160099 · EIH Powder, Porcelain · Dental
Jun 2016 135d
TENEO Dental Treatment Unit and Accessories
K151045 · EIA Unit, Operative Dental · Dental
Jul 2015 95d
INTEGO Family and Accesories
K150909 · EIA Unit, Operative Dental · Dental
Jul 2015 105d
Endo 6:1, T1 Line Endo 6 L, SIRONiTi Apex, T1 Spray
K150750 · EGS Handpiece, Contra- And... · Dental
Jul 2015 101d
ORTHOPHOS SL
K150217 · OAS X-ray, Tomography,... · Radiology
May 2015 98d
T1/T2/T3 TURBINE FAMILY
K131319 · EFB Handpiece, Air-powered,... · Dental
May 2014 388d
SIDEXIS 4
K132773 · LLZ System, Image Processing,... · Radiology
Dec 2013 97d
INCORIS ZI
K123664 · EIH Powder, Porcelain · Dental
Apr 2013 131d
CEREC BLOCS C IN
K123952 · EIH Powder, Porcelain · Dental
Mar 2013 89d
GALILEOS FAMILY
K123070 · OAS X-ray, Tomography,... · Radiology
Mar 2013 165d
INCORIS TZI
K123545 · EIH Powder, Porcelain · Dental
Feb 2013 74d
SIRONA DENTAL CAD/CAM SYSTEM
K111421 · NHA Abutment, Implant,... · Dental
Feb 2012 273d
ORTHOPHOS XG 3D / CEPH
K103711 · OAS X-ray, Tomography,... · Radiology
Mar 2011 92d
SIROLASER ADVANCE, SIROLASER XTEND, SIROLASER XTEND UPGRADED, FONALASER
K103753 · GEX Powered Laser Surgical... · General & Plastic Surgery
Feb 2011 54d
SIRONA CAD/CAM SYSTEM
K100152 · NHA Abutment, Implant,... · Dental
Oct 2010 276d
SIROLASER ADVANCE
K092660 · GEX Powered Laser Surgical... · General & Plastic Surgery
Dec 2009 97d
HELIODENT PLUS
K083344 · EHD Unit, X-ray, Extraoral... · Radiology
Dec 2008 40d
XIOS PLUS WALL-MODULE
K081903 · MUH System, X-ray, Extraoral... · Radiology
Aug 2008 54d
CEREC OPTI SPRAY
K080882 · ELW Material, Impression · Dental
Apr 2008 11d
PERIOSCAN, MODEL: D 3496
K072107 · ELC Scaler, Ultrasonic · Dental
Feb 2008 198d
INCORIS ZI
K062509 · EIH Powder, Porcelain · Dental
Sep 2006 15d
INCORIS AL
K062506 · EIH Powder, Porcelain · Dental
Sep 2006 11d
GALILEOS
K060892 · MUH System, X-ray, Extraoral... · Radiology
Apr 2006 11d
SIROENDO
K052515 · EKX Handpiece, Direct Drive,... · Dental
Mar 2006 198d
SIROLASER
K053161 · GEX Powered Laser Surgical... · General & Plastic Surgery
Jan 2006 65d
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