Planmeca ProMax 10030688

GUDID 06430035420292

Planmeca ProMax, panoramic X-ray imaging system with cephalostat, is an extraoral source X-ray system, which is intended for dental radiographic exami

Planmeca Oy

Stationary panoramic/tomographic dental x-ray system, digital Stationary panoramic dental x-ray system, digital Stationary panoramic dental x-ray system, digital Stationary panoramic dental x-ray system, digital Stationary panoramic dental x-ray system, digital Stationary panoramic dental x-ray system, digital Stationary panoramic dental x-ray system, digital Stationary panoramic dental x-ray system, digital Stationary panoramic dental x-ray system, digital Stationary panoramic dental x-ray system, digital Stationary panoramic dental x-ray system, digital Stationary panoramic dental x-ray system, digital Stationary panoramic dental x-ray system, digital Stationary panoramic dental x-ray system, digital Stationary panoramic dental x-ray system, digital

• Primary Device ID: 06430035420292
• NIH Device Record Key: 68c2af7b-edb6-414c-b718-b77c2c35f204
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Planmeca ProMax
• Version Model Number: ProMax 2D
• Catalog Number: 10030688
• Company DUNS: 368788568
• Company Name: Planmeca Oy
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	06430035420292 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051464

FDA Product Code

• MUH: System,X-Ray,Extraoral Source,Digital

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-10

On-Brand Devices [Planmeca ProMax]

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