DEVICE: Planmeca ProMax (06430035420315)
Device Identifier (DI) Information
Planmeca ProMax
ProMax 3D
In Commercial Distribution
10019566
Planmeca Oy
ProMax 3D
In Commercial Distribution
10019566
Planmeca Oy
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 Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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44245 | Stationary panoramic/tomographic dental x-ray system, digital |
A diagnostic digital dental x-ray system designed for permanent fixture in one location with an extraoral x-ray sensor and source intended to generate and control x-ray beams used in advanced dental imaging applications involving the teeth, jaw, oral cavity, sinus, and/or other maxillofacial structures. It uses digital techniques for image capture, manipulation and display and may include various image processing and analysis capabilities. This system is designed with the capability to produce two or more special purpose dental x-ray examinations: linear scanning, panoramic, cephalometric, linear tomography, spiral tomography, scanograms.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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MUH | System,X-Ray,Extraoral Source,Digital |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K060328 | 000 |
Sterilization
Storage and Handling
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No storage/handling found |
Clinically Relevant Size
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No Device Sizes |
Device Record Status
9188706f-3615-462f-a768-26dc16584648
July 06, 2018
3
August 10, 2016
July 06, 2018
3
August 10, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
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Secondary DI
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Unit of Use DI
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Unit of Use DI Number:
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CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
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No Customer Contact currently defined