Planmeca Sovereign 10032746, 10032747

GUDID 06430035420100

Planmeca Sovereign is a dental operative unit including a dental patient chair. The versatile swivelling enables fluent two-handed and four-handed tre

Planmeca Oy

Dental delivery system
Primary Device ID06430035420100
NIH Device Record Keyde47b4aa-93ac-404b-96f3-02d29fca546d
Commercial Distribution StatusIn Commercial Distribution
Brand NamePlanmeca Sovereign
Version Model NumberClassic
Catalog Number10032746, 10032747
Company DUNS368788568
Company NamePlanmeca Oy
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106430035420100 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EIAUnit, Operative Dental

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-05-05

Devices Manufactured by Planmeca Oy

06430035420599 - Planmeca Romexis2023-06-22 Planmeca Romexis is a modular imaging software for dental and medical use.
06430035420612 - Planmeca Compact2019-11-06 Planmeca Compact i3 is a dental operative unit with a dental patient chair. The unit is equipped with a digital control system a
06430035420605 - Planmeca Viso2019-03-14 The Planmeca Viso -X-ray unit uses cone beam computed tomography (CBCT) to produce three-dimensional (3D) images of the maxillof
06430035420575 - Planmeca Compact2019-02-04 Planmeca Compact i5 is a dental operative unit including a dental patient chair. The unit is equipped with a digital control sys
06430035420551 - Planmeca Viso2018-10-22 The Planmeca Viso -X-ray unit uses cone beam computed tomography (CBCT) to produce three-dimensional (3D) images of the maxillof
06430035420100 - Planmeca Sovereign2018-07-06Planmeca Sovereign is a dental operative unit including a dental patient chair. The versatile swivelling enables fluent two-handed and four-handed tre
06430035420100 - Planmeca Sovereign2018-07-06 Planmeca Sovereign is a dental operative unit including a dental patient chair. The versatile swivelling enables fluent two-hand
06430035420162 - Planmeca Chair2018-07-06 Planmeca Chair is electronically controlled patient chair with swivel funcion allowing the chair to be swivelled 90 degrees to l
06430035420247 - Planmeca SingLED2018-07-06 Planmeca SingLED is a dental operating light providing ultra-bright light with modern LED technology.

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