Address:Asentajankatu 6,Helsinki Uusimaa,FI
Device Description : Planmeca ProMax 3D Max or Maximity is a system intended to produce two-dimension Planmeca ProMax 3D Max or Maximity is a system intended to produce two-dimensional and three-dimensional digital X-ray images of the dento-maxillo-facial, cervical spine and ENT (Ear, Nose Throat) regions.
Device Class : 2
Duns Number: 368788568
Premarket Exempt : No
Prescription Use : Yes
Device Description : Planmeca ProMax 3D Max or Maximity is a system intended to produce two-dimension Planmeca ProMax 3D Max or Maximity is a system intended to produce two-dimensional and three-dimensional digital X-ray images of the dento-maxillo-facial, cervical spine and ENT (Ear, Nose Throat) regions.
Device Class : 2
Duns Number: 368788568
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Planmeca Solanna operating light gives perfect visibility over the entire tr The Planmeca Solanna operating light gives perfect visibility over the entire treatment area with adjustable brightness and colour temperature. The light head moves smoothly to cater the needs of users of all sizes, sitting or standing. The light head with 3-axis movement is easy and effortless to position.The exceptionally long arm enables optimal working conditions for operations of all kinds.
Device Class : 1
Duns Number: 368788568
Premarket Exempt : Yes
Prescription Use : No
Device Description : The Planmeca Viso -X-ray unit uses cone beam computed tomography (CBCT) to produ The Planmeca Viso -X-ray unit uses cone beam computed tomography (CBCT) to produce three-dimensional (3D) images of the maxillofacial and ENT anatomies. Two dimensional (2D) images are produced with tomosynthesis method (panoramic) imaging) as well as conventional 2D radiography (cephalometric imaging, 2D views). In CBCT a cylindrical volume of data is captured in one imaging procedure. The data consists of several hundred sample images which are taken from different directions to cover a certain pre-programmed target area. These samples are used for 3D reconstruction (using a separate 3D reconstruction PC) that can be viewed in three dimensions using separate workstation and Planmeca Romexis software.
Device Class : 2
Duns Number: 368788568
Premarket Exempt : No
Prescription Use : Yes
Device Description : Planmeca Compact i5 is a dental operative unit including a dental patient chair. Planmeca Compact i5 is a dental operative unit including a dental patient chair. The unit is equipped with a digital control system and a user interface with a touch panel. The instrument console includes five instrument locations, with easy instrument change.
Device Class : 1
Duns Number: 368788568
Premarket Exempt : No
Prescription Use : No
Device Description : The Planmeca Viso -X-ray unit uses cone beam computed tomography (CBCT) to produ The Planmeca Viso -X-ray unit uses cone beam computed tomography (CBCT) to produce three-dimensional (3D) images of the maxillofacial and ENT anatomies. Two dimensional (2D) images are produced with tomosynthesis method (panoramic) imaging) as well as conventional 2D radiography (cephalometric imaging, 2D views). In CBCT a cylindrical volume of data is captured in one imaging procedure. The data consists of several hundred sample images which are taken from different directions to cover a certain pre-programmed target area. These samples are used for 3D reconstruction (using a separate 3D reconstruction PC) that can be viewed in three dimensions using separate workstation and Planmeca Romexis software.
Device Class : 2
Duns Number: 368788568
Premarket Exempt : No
Prescription Use : Yes
Device Description : Planmeca Compact i3 is a dental operative unit with a dental patient chair. The Planmeca Compact i3 is a dental operative unit with a dental patient chair. The unit is equipped with a digital control system and a user interface with a touch panel. The instrument console includes five instrument locations, with easy instrument change. The chair and the unit can be swiveled and it is suitable for both right and left-handed use.
Device Class : 1
Duns Number: 368788568
Premarket Exempt : No
Prescription Use : No