DEVICE: Impregum™ Penta™ Soft Quick Step Medium Body (J001702011328370)
Device Identifier (DI) Information
Impregum™ Penta™ Soft Quick Step Medium Body
P31771
In Commercial Distribution
P31771
3M Deutschland GmbH
P31771
In Commercial Distribution
P31771
3M Deutschland GmbH
3M™ ESPE™ Impregum™ Penta™ Soft Quick Step Medium Body Polyether Impression Material Intro Kit, P31771
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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58399 | Dental material mixing nozzle |
A device designed for mixing inactive compounds during a dental procedure to produce a functional dental restorative/impression material which may be applied directly to the oral cavity/teeth of the patient or used for some other dental application. It is nozzle-shaped and has an integral mixing mechanism (e.g., spiralled channels). It is attached to the end of a cartridge consisting of two tubes so that the compounds are mixed as they are expressed simultaneously from the tubes through the nozzle. This is a single-use device.
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Active | false |
60885 | Dental material cartridge-plunging applicator, two-component, manual |
A hand-held manual device intended to dispense a two-component dental material (e.g., impression material) [not included] from a cartridge directly into the mouth or into another device (e.g., impression tray). It is typically a pistol-like device with a cartridge-plunging mechanism; typically, a dental material mixing nozzle is attached to the distal tip of the cartridge during use. This is a reusable device after appropriate cleaning.
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Active | false |
35864 | Polyether dental impression material |
An elastomeric, polyether-based material capable of reacting to form a rubber-like substance used to reproduce the structure of a patient's teeth and gums, or other oral anatomy, after being placed on an impression tray and inserted into the mouth. This is a single-use device.
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Active | false |
16658 | Dental impression material adhesive |
A liquid material specifically made to give adhesion of an impression material to the impression tray. After application, this device cannot be reused.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
EID | SYRINGE, RESTORATIVE AND IMPRESSION MATERIAL |
ELW | MATERIAL, IMPRESSION |
EBH | MATERIAL, IMPRESSION TRAY, RESIN |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
af362263-1824-456a-9967-68817cb87f7e
February 03, 2023
5
September 24, 2016
February 03, 2023
5
September 24, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)634-2249
3Mhealthcarecompliance@mmm.com
3Mhealthcarecompliance@mmm.com