Planmeca ProMax 30003112

GUDID 06430035420490

Planmeca ProMax 3D Mid, is a panoramic and cephalometric x-ray unit, which uses Cone Beam Computed Tomography (CBCT) to produce three-dimensional imag

Planmeca Oy

Stationary panoramic/tomographic dental x-ray system, digital
Primary Device ID06430035420490
NIH Device Record Keybef7f7a3-e23d-4e0c-9080-d382f8bb2112
Commercial Distribution StatusIn Commercial Distribution
Brand NamePlanmeca ProMax
Version Model NumberProMax 3D Mid
Catalog Number30003112
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 Perscriptiontrue
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS106430035420490 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MUHSystem,X-Ray,Extraoral Source,Digital

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 Date2016-09-19

On-Brand Devices [Planmeca ProMax]

06430035420513Planmeca ProMax 3D Max or Maximity is a system intended to produce two-dimensional and three-dim
06430035420506Planmeca ProMax 3D Max or Maximity is a system intended to produce two-dimensional and three-dim
06430035420490Planmeca ProMax 3D Mid, is a panoramic and cephalometric x-ray unit, which uses Cone Beam Comput
06430035420483Planmeca ProMax 3D Plus, is a panoramic and cephalometric x-ray unit, which uses Cone Beam Compu
06430035420476Planmeca ProMax 3D, is a three dimensional Cone Beam Computed Tomography (CBCT) x-ray system, wh
06430035420469Planmeca ProMax 3D, is a three dimensional Cone Beam Computed Tomography (CBCT) x-ray system, wh
06430035420452Planmeca ProMax, panoramic X-ray imaging system with cephalostat, is an extraoral source X-ray s
06430035420445Planmeca ProMax, panoramic X-ray imaging system with cephalostat, is an extraoral source X-ray s
06430035420407Planmeca ProMax 3D Plus, is a panoramic and cephalometric x-ray unit, which uses Cone Beam Compu
06430035420377Planmeca ProMax 3D Mid, is a panoramic and cephalometric x-ray unit, which uses Cone Beam Comput
06430035420353Planmeca ProMax 3D Max or Maximity is a system intended to produce two-dimensional and three-dim
06430035420346Planmeca ProMax 3D, is a three dimensional Cone Beam Computed Tomography (CBCT) x-ray system, wh
06430035420315Planmeca ProMax 3D, is a three dimensional Cone Beam Computed Tomography (CBCT) x-ray system, wh
06430035420292Planmeca ProMax, panoramic X-ray imaging system with cephalostat, is an extraoral source X-ray s

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