DEVICE: Planmeca ProMax (06430035420445)
Device Identifier (DI) Information
Planmeca ProMax
ProMax 2D
In Commercial Distribution
30003108
Planmeca Oy
ProMax 2D
In Commercial Distribution
30003108
Planmeca Oy
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 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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43369 | Stationary panoramic 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 to produce panoramic (wide field of view) x-ray images of the teeth, jaw and oral cavity structures. It consists of basic modular configurations that can be upgraded by the addition of hardware, software or other components. The data is either from analogue-to-digital conversion techniques imaging or by digital imaging.
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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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K051464 | 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
e99ea6c6-775b-4abf-9950-e26c9ef00d9c
December 17, 2020
4
September 19, 2016
December 17, 2020
4
September 19, 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