Planmeca Oy

Address:Asentajankatu 6,Helsinki Uusimaa,FI

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

System,X-Ray,Extraoral Source,Digital (MUH) (4) Light, Operating, Dental (EAZ) (1) System, Image Processing, Radiological (LLZ) (1) Chair, Dental, With Operative Unit (KLC) (1) Unit, Operative Dental (EIA) (1) Unit, X-Ray, Extraoral With Timer (EHD) (1) X-Ray, Tomography, Computed, Dental (OAS) (1)

Premarket Exempt

No Yes

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Planmeca Sovereign - 06430035420100 Catalog Number : 10032746, 10032747

Device Description : Planmeca Sovereign is a dental operative unit including a dental patient chair. Planmeca Sovereign is a dental operative unit including a dental patient chair. The versatile swivelling enables fluent two-handed and four-handed treatment sequences as well as both left-handed and right-handed use. The unit is equipped with a digital control system with graphical user interface (GUI) to offer ease of use.The instrument console includes six instrument locations, with easy instrument interchange.

Device Class : 1

Duns Number: 368788568

Premarket Exempt : No

Product Code : EIA

Prescription Use : No

Device Count : 1

Planmeca Chair - 06430035420162 Catalog Number : 10026000

Device Description : Planmeca Chair is electronically controlled patient chair with swivel funcion al Planmeca Chair is electronically controlled patient chair with swivel funcion allowing the chair to be swivelled 90 degrees to left and right. The chair has an integrated foot control for automatic chair positions and manual movements. The chair can be equipped with optional foldable knee-break.

Device Class : 1

Duns Number: 368788568

Premarket Exempt : No

Product Code : KLC

Prescription Use : No

Device Count : 1

Planmeca SingLED - 06430035420247 Catalog Number : 10020815

Device Description : Planmeca SingLED is a dental operating light providing ultra-bright light with m Planmeca SingLED is a dental operating light providing ultra-bright light with modern LED technology.

Device Class : 1

Duns Number: 368788568

Premarket Exempt : No

Product Code : EAZ

Prescription Use : No

Device Count : 1

Planmeca Romexis - 06430035420254 Catalog Number :

Device Description : Planmeca Romexis is a modular imaging software for dental and medical use,

Device Class : 2

Duns Number: 368788568

Premarket Exempt : No

Product Code : LLZ

Prescription Use : No

Device Count : 1

Planmeca ProMax - 06430035420292 Catalog Number : 10030688

Device Description : Planmeca ProMax, panoramic X-ray imaging system with cephalostat, is an extraora Planmeca ProMax, panoramic X-ray imaging system with cephalostat, is an extraoral source X-ray system, which is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures.

Device Class : 2

Duns Number: 368788568

Premarket Exempt : No

Product Code : MUH

Prescription Use : Yes

Device Count : 1

Planmeca ProSensor - 06430035420308 Catalog Number : 10037245

Device Description : Planmeca ProSensor, digital intraoral X-ray imaging system, is an accessory to d Planmeca ProSensor, digital intraoral X-ray imaging system, is an accessory to dental intraoral x-ray devices. It is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures.

Device Class : 2

Duns Number: 368788568

Premarket Exempt : No

Product Code : EHD

Prescription Use : Yes

Device Count : 1

Planmeca ProMax - 06430035420315 Catalog Number : 10019566

Device Description : Planmeca ProMax 3D, is a three dimensional Cone Beam Computed Tomography (CBCT) Planmeca ProMax 3D, is a three dimensional Cone Beam Computed Tomography (CBCT) x-ray system, which is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures.

Device Class : 2

Duns Number: 368788568

Premarket Exempt : No

Product Code : MUH

Prescription Use : Yes

Device Count : 1

Planmeca ProOne - 06430035420322 Catalog Number : 30010469

Device Description : Planmeca ProOne is a dental panoramic X-ray imaging system, which is intended fo Planmeca ProOne is a dental panoramic X-ray imaging system, which is intended for dental radiographic examination and diagnosis of teeth, jaw and oral structures.

Device Class : 2

Duns Number: 368788568

Premarket Exempt : No

Product Code : MUH

Prescription Use : Yes

Device Count : 1

Planmeca ProMax - 06430035420346 Catalog Number : 30016943

Device Class : 2

Duns Number: 368788568

Premarket Exempt : No

Product Code : MUH

Prescription Use : Yes

Device Count : 1

Planmeca ProMax - 06430035420353 Catalog Number : 10020019

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

Product Code : OAS

Prescription Use : Yes

Device Count : 1

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